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Hayama, Y., & Inoue, T. (2012). The effects of deep breathing on 'tension-anxiety' and fatigue in cancer patients undergoing adjuvant chemotherapy. Complementary Therapies in Clinical Practice, 18, 94–98.

Study Purpose

To investigate the effect of a deep breathing intervention, incorporated within conventional nursing care, on tension-anxiety and fatigue experienced by Japanese women with gynecologic cancer undergoing adjuvant chemotherapy for the first time.

To reduce tension-anxiety and fatigue through deep breathing that incorporated elements of exercise.

Intervention Characteristics/Basic Study Process

The deep breathing intervention was initiated for patients in the intervention group. Each patient received 15 minutes of guidance from the researcher using a DVD and pamphlets. The intervention was performed with nursing assistance pre- and postchemotherapy, with the latter given on the second, fourth, and sixth days. The control group received treatment with the usual chemotherapy and nursing care.

Sample Characteristics

  • The study was comprised of 23 women.
  • Mean age was 53.6 years (standard deviation [SD] = 9.4 years) in the intervention group and 61.7 years (SD = 9.8 years) in the control group.
  • All patients were diagnosed with gynecologic cancers, including uterine (54.5%), ovarian, cervical, and peritoneal carcinomatosis. Cancer stage ranged from I (54.5%) to III.
  • Patients were included in the study if they had a recent diagnosis, were postoperative and receiving their first administration of adjuvant chemotherapy, were literate in Japanese, and were willing to participate.
  • Patients were excluded if they were younger than 20 years and had received recent psychological treatment (including medication and psychotherapy) and/or recent asthma treatment.

Setting

  • Single site
  • Inpatient
  • Osaka, Japan

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study used a randomized, controlled trial design.

Measurement Instruments/Methods

  • Profile of Mood States (POMS)–Short Form (Japanese version):  tension-anxiety and fatigue subscales assessed pre- and posttherapy
  • Cancer Fatigue Scale (CFS), subscales of subjective fatigue:  physical, affective, and cognitive assessed pre- and posttherapy

Results

There were no statistically significant differences between groups in terms of age, diagnosis, or cancer clinical stage or treatment type (p > 0.05). Prechemotherapy data showed no significant differences between the intervention and control groups in the previously mentioned measurement tools. The postchemotherapy tension-anxiety scores were lower in the intervention group (p = 0.01). Both groups showed significant reductions in tension-anxiety scores (both p = 0.00). The postchemotherapy physical and total fatigue scores of the intervention group were significantly lower than those of the control group (physical, p = 0.04; total, p = 0.04).

Conclusions

The study demonstrated that the tension-anxiety and fatigue scores of patients undergoing chemotherapy for gynecologic cancers were lowered when the nurses assisted them with deep breathing for a short period in addition to providing conventional nursing care provided pre- and postchemotherapy. The prominent features of the study were that it used a program that combined three deep breathing techniques and was of short duration (10 minutes).

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The nurse-to-patient ratio for teaching was 1:1.
  • The study was limited to patients with gynecologic cancer and had a limited time period evaluated for fatigue (fatigue can worsen as chemotherapy continues). 
  • The study needs to be reproducible in different facilities and with a larger sample size. 
  • The study lacked an attentional control.

Nursing Implications

These are very simple exercises that can be taught to patients and be performed even while they are receiving chemotherapy. In addition to usual nursing care, nurses can contribute to reducing patients’ tension-anxiety and fatigue by assisting them in performing deep breathing.

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Hawley, P.H., & Byeon, J.J. (2008). A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer. Journal of Palliative Medicine, 11, 575–581.

Study Purpose

To determine the efficacy of sennoside-based regimens on the proportion of total days with at least one bowel movement (BM) per day.

Intervention Characteristics/Basic Study Process

During phase I, the first 30 consecutive eligible patients admitted to the ward received docusate plus sennosides (DS) for management of constipation. Dosing was as follows.

  • Opioid-naive patients received docusate sodium 200 mg BID.
  • For those on opioids or had no BM in 48 hours, the starting dose or next dose was docusate 200 mg BID plus sennosides 17.2 mg every bedtime.
  • If patients had no BM in the next 48 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg BID.
  • If patients had no BM in the next 24 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg TID.
  • If patients still had no BM after 24 hours, they received docusate sodium 200 mg TID plus sennosides 25.8 mg TID. 

During phase II, the next 30 eligible patients with constipation received sennosides only. Dosing was as follows.

  • Patients received sennosides 17.2 mg every bedtime.
  • For those on opioids or had no BM in 48 hours, the starting dose or next dose was sennosides 17.2 mg BID.
  • If patients had no BM in the next 24 hours, they received sennosides 17.2 mg TID.
  • Finally, if patients had no BM after 24 hours, they received sennosides 25.8 mg TID.

Rescue laxatives included lactulose, a suppository, or enema as needed. Only 12 days of bowel protocol were abstracted from the medical record.

Sample Characteristics

  • The study reported on a sample of 60 patients.
  • Mean patient age was 59.1 years (SD = 14.8, range 24–87) in the DS group and 62.9 years (SD =13.9, range 25–85) in the sennosides group.
  • The sample comprised 45 women and 15 men.
  • Fourteen patients in the sennosides group had genitourinary cancer, and seven patients in the DS group had breast cancer. 
  • Eighty percent of patients were on opioids and 72% were admitted for symptom control.

Setting

  • Single site
  • Inpatient
  • Vancouver Center of British Columbia Cancer Agency in Canada

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability to end-of-life and palliative care.

Study Design

This was a nonrandomized, nonblinded, sequential cohort study.

Measurement Instruments/Methods

Nursing chart review

Results

  • The mean study observation period was eight days (range 5–12 days).
  • Eighty percent of patients in the sennosides group had a BM on at least 40% of days compared with 60% of the DS group (p = 0.09). However, if patients not taking opioids were excluded, the sennosides group had better results (76% versus 50% of days) than the DS group (not significant).
  • Fifty-seven percent of patients in the DS group required additional interventions (lactulose, suppositories, or enemas) compared to 40% in the sennosides group.
  • Twenty-seven percent of patients in the sennosides group reported diarrhea compared to 13% in the DS group.

Conclusions

Sennosides only produced more BMs than DS.

Limitations

  • The study had a small sample size (fewer than 100).
  • The design was not randomized.
  • More patients with genitourinary cancer were recruited in the sennosides group than the DS group, and 90% of patients in the DS group were receiving opioids; therefore, an even comparison in diagnosis was not reflected.
  • The dosage of sennosides was higher overall in the sennosides group than the DS group, which could have influenced the results as well.
  • Conclusions were based on a chart review, which was performed to look at side effects, versus interview. Data may have been lost if patients were not asked or side effects were not recorded.

Nursing Implications

Adding a stool softener such as docusate does not necessarily produce superior results than those seen with a laxative alone. However, additional randomized, double-blind studies should be conducted before conclusions and evidence into practice are drawn. The usefulness of this study is questionable because of its design and execution issues.

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Hawley, P., Hovan, A., McGahan, C.E., & Saunders, D. (2014). A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Supportive Care in Cancer, 22, 751–761.

Study Purpose

To determine if honey swished, held, and swallowed reduced the severity of radiation-induced oral mucositis (ROM)

Intervention Characteristics/Basic Study Process

Honey and placebo gel were provided in 5 mL packets to be taken after salt/bicarbonate oral rinses four times a day after meals and after radiotherapy or approximately the same time on non-treatment days. Participants were to pour the product into their mouth, circulate it for 30 seconds, and swallow. Subjects were instructed not to eat, drink, or rinse their mouth for 30 minutes following swallowing the honey or placebo. Treatment started on the first day of radiation and continued for seven days following the last radiation treatment. Visits to the oral oncology/dentistry department were scheduled weekly until mucositis was resolved. During each visit, an oral examination was done for mucositis severity rating, a brief questionnaire was conducted, and weight was obtained. Unused treatment medication was collected at the last visit to measure compliance.

Sample Characteristics

  • N = 81  
  • MEAN AGE: Honey arm: 56.8 years, placebo arm: 59.5 years
  • MALES: Honey arm: 81%, placebo arm: 84%; FEMALES: Honey arm: 19%, placebo arm: 16%
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer—hypopharynx, larynx, nasopharynx, oral cavity, oropharynx
  • OTHER KEY SAMPLE CHARACTERISTICS: Radiation therapy of ≥ 50 Gy; 62% had concurrent chemotherapy; Caucasian

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Outpatient 
  • LOCATION: Vancouver and Sudbury, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, randomized, placebo-controlled, investigator-initiated

Measurement Instruments/Methods

  • Sialometry and mucositis severity scales from the Radiation Therapy Oncology Group (RTOG)
  • World Health Organization (WHO) Oral Mucositis Scale

Results

There were no differences found between the treatment and placebo arms for any of the three outcome assessment scales of mucositis for quality of life, symptom scores, or sialometry. Both the honey (35%) and placebo (43%) groups had lower than expected rates of ≥ grade 3 mucositis.

Conclusions

The honey, when used as directed in this study, did not significantly decrease the severity of ROM. The treatment and placebo groups were well matched, and the blinding was effective. The dropout rate was high (honey: 57%, placebo: 52%, those receiving concurrent chemotherapy: 59%). Most of the dropouts were related to nausea. Patients receiving radiation only had a dropout rate of 48%. Only 48 patients had complete weekly mucositis assessments.

Limitations

  • Small sample (< 100)
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: The initial plan for the study was to enroll 180 subjects. The study was terminated at planned interim analysis when 106 patients had been recruited.

Nursing Implications

There have been varied outcomes in studies of honey for the treatment of mucositis. Differences in methodology could explain at least part of the variability. In this study, the subjects tolerated the honey poorly because of nausea and gagging, and a couple patients experienced a burning sensation. The authors referenced a study from New Zealand in which a honey mouthwash was used because undiluted honey caused extreme nausea, vomiting, and stinging sensations. Potential reasons for the lack of efficacy seen could be that the mucositis tools may not have had adequate sensitivity to reveal any clinical difference between or the osmotic effect of the honey and placebo. Also, Christian areas like Canada, New Zealand, and Great Britain, where honey does not have any special significance, may differ from Muslim areas that have the Koran’s references to honey’s healing powers.

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Hawkins, A.S., Yoo, D.C., Movson, J.S., Noto, R.B., Powers, K., & Baird, G.L. (2014). Administration of subcutaneous buffered lidocaine prior to breast lymphoscintigraphy reduces pain without decreasing lymph node visualization. Journal of Nuclear Medicine Technology, 42, 260–264. 

Study Purpose

To assess whether anesthetizing the skin with buffered lidocaine before performing breast lymphoscintigraphy reduces pain

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the control group without lidocaine or the experimental group in which the procedure was preceded by lidocaine injection. Patients were asked to rate their pain levels before and immediately after injections for the procedure. All patients received two injections and were were masked from knowing whether one of them was lidocaine.

Sample Characteristics

  • N = 49   
  • MEAN AGE = 61.4 years
  • AGE RANGE = 34–87 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast cancer

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Rhode Island

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • 0–10 numeric pain rating scale

Results

No difference in preprocedure pain levels existed between groups. Those who received lidocaine reported less of an increase in pain postprocedure. No difference in lymph node detection existed between groups.

Conclusions

Administration of local anesthetic prior to breast lymphoscintigraphy was associated with lower pain severity after the procedure.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Limited reporting of statistical results and methods

Nursing Implications

Authors point out that local anesthesia prior to lymphoscintigraphy is not common practice, due to the assumption that any benefit would be outweighed by the pain associated with additional needle sticks. Some patients may feel significant pain during this procedure, and findings from this study suggest an approach to reduce pain with this experience. Authors discuss the findings in terms of the rationale for using a buffered lidocaine solution and implications for practical application and needed lymph node visualization.

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Hatoum, H.T., Lin, S.J., Buchner, D., & Cox, D. (2012). Comparative clinical effectiveness of various 5-HT3 RA antiemetic regimens on chemotherapy-induced nausea and vomiting associated with hospital and emergency department visits in real world practice. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 20(5), 941–949.

Study Purpose

To compare the risk of chemotherapy-induced nausea and vomiting (CINV) events for various 5-HT3 receptor antagonists (RAs) in patients who received moderately (MEC) or highly emetogenic chemotherapy (HEC) by evaluating hospital or emergency department (ED) admissions

Intervention Characteristics/Basic Study Process

Patients with breast cancer who received adjuvant chemotherapy with cyclophosphamide within four months after surgery and patients with lung cancer who were initiated on carboplatin or cisplatin-based chemotherapy within the study time frame (January 1, 2005, through June 20, 2008) were identified using the PharMetrics database. CINV events associated with hospital and ED admissions were extracted using claims with ICD-9-CM codes for nausea, vomiting, or dehydration.  

In each cohort, patients were stratified into two groups, one consisting of patients initiated and maintained on palonosetron as the only 5-HT3 RA antiemetic, the other with patients who were initiated on one of the older 5-HT3 RAs and maintained on the same agent or alternated throughout the study duration between the older 5-HT3 RA and palonosetron, either as single agents or in combinations. The use of aprepitant and dexamethasone was used in both cohorts.

Sample Characteristics

The study consisted of 4,868 patients with breast cancer and 7,106 patients with lung cancer (5,414 treated with carboplatin, 1,692 treated with cisplatin).

The median age in all cohorts ranged from 53–65 years.

The breast cancer cohort was 100% female.

The carboplatin-treated lung cancer cohort was 46.5% female and 53.5% male.

The cisplatin-treated lung cancer cohort was 40.3% female and 59.7% male.

The patients in the breast cancer and carboplatin-treated lung cancer cohorts were considered to be treated with moderately emetogenic chemotherapy (MEC). The cisplatin-lung cancer cohort was considered to be treated with highly emetogenic chemotherapy (HEC). The authors did control for differences in age, Charlson comorbidity index (CCI) score, gender (lung cancer cohorts), cyclophosphamide dose per square meter per cycle (breast cancer cohort), and cisplatin and carboplatin treatment days (lung cancer cohorts).

Setting

Site and setting type was not indicated. Data was analyzed using pooled patient information from PharMetrics database.

Phase of Care and Clinical Applications

  • Patients were in active treatment.
  • This study has application to elderly care.

Study Design

This was a retrospective data analysis.

Measurement Instruments/Methods

  • Patient comorbidities for the six-month baseline period prior to the study index date were calculated using the CCI.
  • The study population was selected using the PharMetrics database.

Results

Based on the results presented by the authors, patients with breast or lung cancer treated with HEC or MEC, when initiated and maintained on palonosetron throughout chemotherapy, experienced significantly reduced risk of hospital- and ED-associated CINV events compared to patients who received other 5-HT3 RA-based regimens. In all three cohorts, the p value was < 0.0001. The results of the data analysis do show superiority of palensetron in reducing such events, but a number of variables and limitations may impact the results.

Conclusions

Antiemetic regimens containing palonosetron may be more effective in reducing severe, uncontrolled CINV than other 5-HT3 agents; however, firm conclusions cannot be drawn because of study design limitations and risks of bias.

Limitations

  • No appropriate control group was included.
  • The lead author was a paid consultant to Easai, Inc., the marketer of oalonosetron in the USA. Easai, Inc was also the sponsor of the study. The other authors are employees of Easai, Inc. This has the potential to lead to further selection bias of the patient population.
  • A large variable that was unaccounted for was the varying doses of chemotherapy. 
    • The average dose of cyclophosphomide used in the breast cancer cohort was on the lower end of dosing. Cyclophosphomide is typically given in a dose of 300-600 mg/m2 as adjuvant therapy to patients with breast cancer depending on the selected regimen. The average dose used in patients in this study was 414 mg.
    • Only 19% of patients treated with cisplatin were treated with guideline recommended triplet antiemetic therapy.
  • Though an effort was made to control for comorbid conditions in the cohorts, variables such as differences in chemotherapy doses were not a part of the analysis.

Nursing Implications

The study is helpful because it was an analysis of a large group of patients. It also seeks to provide meaningful conclusions for patients. Although identifying interventions for the reduction of CINV in patients can aid in quality of life and ability to receive treatment in a timely manner, looking at the significance of CINV reduction in preventing serious events such as ED visits or hospitalizations is also important.

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Hately, J., Laurence, V., Scott, A., Baker, R., & Thomas, P. (2003). Breathlessness clinics within specialist palliative care settings can improve the quality of life and functional capacity of patients with lung cancer. Palliative Medicine, 17(5), 410–417.

Intervention Characteristics/Basic Study Process

Potential patients were referred to a highly experienced palliative care physiotherapist clinic. Patients were seen by the physiotherapist at three sessions, each lasting as long as 90 minutes. Intervention consisted of breathing retraining, simple relaxation techniques, activity pacing, and psychosocial support.

Sample Characteristics

The study reported on a sample of 30 patients with non-small cell lung cancer, small cell lung cancer, or mesothelioma (pleural effusion excluded) who experienced breathlessness not less than one month after completion of any active treatment; 68 patients were referred, 17 did not fulfill the criteria, 4 declined, and 2 were too ill to treat. Forty-five entered the study, and 15 deteriorated or died before completion. The median age was 71 years; 24 were men, and 6 were women.

Setting

The study was conducted in an outpatient clinic in the United Kingdom.

Study Design

  • Uncontrolled study
  • Nonrandomized
  • Referred patients

Measurement Instruments/Methods

Tools completed by the therapist at each visit

  • Current Respiratory Symptoms—adapted from two scales (Medical Research Council and Respiratory Symptom Questionnaire); patients were asked to score how often they were breathless, ranging from most or all the time to less than once a week
  • Functional Capacity Scale adapted from above tools; patients scored their ability to climb hills or stairs without breathlessness to experiencing breathlessness at rest
  • Sputum production scale

Self-assessment tools completed by patients at baseline and following the intervention (four to six weeks)

  • Rotterdam symptom checklist
  • VAS: breathing at worst and at best in the proceeding 24 hours as well as distress caused by breathlessness (0–10 where 10 = extreme distress)
  • Things that improve breathing (in the clinic, patients were taught techniques and coping strategies likely to improve their feeling of breathlessness); the patients were asked to score 20 helpful strategies at baseline and at the last visit on a VAS (1–10 where 10 = extremely helpful).
  • Quality-of-life questionnaire
  • Therapist recorded patients’ verbatim comments in free narrative form and added own comments.

Results

Statistical analysis of baseline data on 12 patients who were unable to complete the study compared to 30 patients who completed the study showed significantly lower Functional Capacity Scale scores (p = 0.04) at first assessment. For patients who completed the study, a highly significant (p < 0.001) change in frequency of reported breathlessness was found. A decrease existed in reported breathlessness, from 97% reporting it at least once or twice a day, 73% several times a day, and 27% most of the time to 27% experiencing dyspnea several times a day and 3% most of the time at the final visit. A statistically significant change was seen between study entry and completion (p < 0.001) in functional capacity. Overall, 19 improved function, 9 remained stable, and 2 deteriorated.

No change in sputum production was found.

Rotterdam symptom checklist:

Significant changes were seen in the physical distress scores and activity levels (no p value given). Change in psychological distress scores were borderline.

Degree of breathlessness:

Significant improvement (p < 0.001) was found in all three parameters—breathing at best, breathing at worst, and distress caused by breathlessness.

Intervention strategies:

On study entry, patients were asked to score 20 strategies that were likely to improve feelings of breathlessness. Examples of interventions include activity pacing, abdominal breathing, slowing down, relaxation exercises, not worrying, accepting the situation, and positive thinking.

Patients reported that all of the techniques they learned were helpful and improved breathlessness. Patients reported that massage and the use of bronchodilator drugs were not helpful.

Quality of life:

Significant improvements were seen in decrease in time spent lying down (p = 0.02), improved bodily strength (p = 0.03), and increase in things that made patients happy (p = 0.04). Patients reported an increased ability to do things and improved quality of life.

Qualitative data:

The following themes were extracted from the narrative data: difficulty adjusting, issues around death, effects of treatments, and therapies’ impact on daily life.

Limitations

The study was uncontrolled. A major limitation of the study is that it is a nonrandomized trial of referred patients. Impossible to know are the implied bias in patients who were referred or the true effect of the intervention without a control group. It was based on a prior study, with the time period shortened because of the loss of patients in the earlier study’s sample.

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Hatakeyama, H., Takahashi, H., Oridate, N., Kuramoto, R., Fujiwara, K., Homma, A., . . . Fukuda, S. (2015). Hangeshashinto improves the completion rate of chemoradiotherapy and the nutritional status in patients with head and neck cancer. ORL: Journal for Oto-Rhino-Laryngology and Its Related Specialties, 77, 100–108. 

Study Purpose

To investigate the effect of hangeshashinto to relieve chemotherapy-induced oral mucositis

Intervention Characteristics/Basic Study Process

Patients were to gargle three times daily with 2.5 g hangeshashinto (TJ-14) in 50 ml of water and rinse the oral cavity for about five seconds. Patients were instructed not to swallow it and not eat or drink anything for 30 minutes. Patients who received the intervention were compared to patients who did not. Measurements were done at baseline and at eight weeks.

Sample Characteristics

  • N = 57, only 12 received the intervention  
  • MEAN AGE = 59.5 years
  • AGE RANGE = 40–75 years
  • MALES: 93%, FEMALES: 7%
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Oropharyngeal and hypopharyngeal cancers; total radiation dose of 70 Gy and cisplatin
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority of patients had stage IV disease.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Nonrandomized two-group prospective study

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE)
  • Bioimpedance for body composition
  • Measurement of food intake

Results

No significant differences in maximum grade of mucositis or daily morphine dose existed. Oral intake and body weight were improved in those who took the hangeshashinto, but no comparative information on this measure from the control group was provided. The radiation completion rate was higher in the treated group (p = 0.045). Twenty-five percent of patients would not continue to use the gargle because of the bitter taste, nausea, vomiting, and refusal to wait 30 minutes before eating.

Conclusions

The findings do not show a benefit of hangeshashinto gargle on mucositis severity or associated pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Very few patients actually received the intervention. Little comparative information is provided. The timing of measurement was not clearly reported.

Nursing Implications

This study did not show the effectiveness of hangeshashinto to prevent or reduce the severity of oral mucositis in patients with head and neck cancer receiving combined radiation and chemotherapy. Multiple report limitations are noted.

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Hata, T., Honda, M., Kobayashi, M., Toyokawa, A., Tsuda, M., Tokunaga, Y., . . . Mishima, H. (2015). Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: A multicenter randomized phase II study (APOLLO). Cancer Chemotherapy and Pharmacology, 76, 1209–1215. 

Study Purpose

To evaluate whether mixing dexamethasone with an oxaliplatin intravenous infusion can reduce venous pain associated with the infusion

Intervention Characteristics/Basic Study Process

Patients receiving either ​capecitabine and oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) chemotherapy were randomly assigned to the experimental or control groups. In the experimental group, 1.65 mg of dexamethasone was mixed with a 5% glucose solution in which 130 mg/m2 was dissolved. The resulting mixture was infused over two hours. Those in the control group received the same infusion without the addition of dexamethasone. Patients were evaluated over four treatment cycles.

Sample Characteristics

  • N = 48
  • MEAN AGE = 66 years (range = 46–81 years)
  • MALES: 79%, FEMALES: 21%
  • KEY DISEASE CHARACTERISTICS: All patients had colorectal cancers and were receiving regimens containing oxaliplatin.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Verbal Rating Scale (VRS) for pain
  • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Results

The incidence of grade 2 or greater venous pain based on the CTCAE was 33.3% in patients receiving steroids and 56% in those who did not (based on only 22 patients). The relative risk of venous pain was 0.60 (95% CI, 0.31–1.16).

Conclusions

Patients who received dexamethasone with oxaliplatin tended to experience less venous pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The study was slightly underpowered.

Nursing Implications

In this study, the incidence of severe venous pain during oxaliplatin infusion was lower with the addition of dexamethasone to the infusion. It has been suggested that mixing dexamethasone may be an option for patients with venous pain or phlebitis caused by chemotherapy. Additional research confirming the efficacy of this approach is needed.

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Hassler, M.R., Elandt, K., Preusser, M., Lehrner, J., Binder, P., Dieckmann, K., . . . Marosi, C. (2010). Neurocognitive training in patients with high-grade glioma: A pilot study. Journal of Neuro-Oncology, 97, 109–115.

Study Purpose

To evaluate the effectiveness of small group neurocognitive training to improve cognitive impairment in patients with brain tumors

Intervention Characteristics/Basic Study Process

Pre- and post-intervention cognitive testing was performed. The 10-week-long intervention consisted of 90-minute weekly group sessions of holistic mnemonic training, which included exercises to train perception, concentration, attention, memory, retentiveness, verbal memory, and creativity.

Sample Characteristics

  • A total of 11 patients were enrolled in the study.
  • Participants' ages ranged from 23–73 years (median = 50 years).
  • The sample was 64% male and 36% female.
  • Patients had been diagnosed with glioblastoma multiforme (n = 6) or anaplastic gliomas (n = 5).
  • Time since initial diagnosis ranged from 10–42 months (median = 15 months).
  • Every participant had received treatment that included surgery, radiation therapy, and adjuvant chemotherapy with temozolomide. One subject also received hydroxyurea and imatinib in addition to temozolomide.
  • Three subjects had tumor recurrence 3–28 months prior to study participation; none underwent additional surgery, and further treatment with radiation or chemotherapy was not provided. 
  • All subjects were taking antiepileptic medications; however a variety of drugs were used. 
  • Subjects varied in professional and educational background, but actual information was not provided.

Setting

  • Single site
  • Outpatient setting
  • Vienna, Austria

Phase of Care and Clinical Applications

  • Patients were undergoing long-term follow-up.
  • The study has applicability for late effects and survivorship.

Study Design

Pilot study with pre-/post-test design

Measurement Instruments/Methods

  • Trail Making Test–A (TMT-A)    
  • Trail Making Test–B (TMT-B)
  • Hopkins Verbal Learning Test (HVLT)
  • Controlled Oral Word Association Test (COWAT)

Results

Although comparison of mean group differences found improvement in all neuropsychological tests, separate dependent t-tests revealed statistically significant improvement only in verbal memory total learning (p < 0.05) as measured by the HVLT. Significant improvement was not seen in verbal memory delayed recall (p = 0.11) as measured by the HVLT, psychomotor speed (p = 0.22) as measured by the TMT-A, sustained attention (p = 0.17) as measured by the TMT-B, or verbal fluency (p = 0.29) as measured by the COWAT.

Conclusions

Significant improvement was found in verbal memory (total learning). However, it is not possible to distinguish whether the improvement was a benefit of the intervention or resulted from practice effects associated with the repeated measures occurring 12 weeks from baseline. Additionally, any assumptions regarding effectiveness of the intervention would need to be supported by a larger sample with an appropriate comparison control group.

Limitations

  • The sample was small, with less than 30 participants.
  • The lack of a comparison control group or randomization limited the generalizability of results and the feasibility of the intervention.

Nursing Implications

Although neurocognitive training has been suggested as a potential intervention for cognitive impairment, further studies are needed (including feasibility). Effectiveness of this intervention cannot be established based on this pilot study.

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Hashemi, A., Bahrololoumi, Z., Khaksar, Y., Saffarzadeh, N., Neamatzade, H., & Foroughi, E. (2015). Mouth-rinses for the prevention of chemotherapy induced oral mucositis in children: A systematic review. Iranian Journal of Pediatric Hematology and Oncology, 5, 106–112.

Purpose

STUDY PURPOSE: To evaluate studies on basic oral care interventions to update evidence-based practice guidelines for preventing oral mucositis in patients with cancer receiving chemotherapy
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed and Google Scholar
 
KEYWORDS: Cancer, chemotherapy, children, mouthwash, and mucositis
 
INCLUSION CRITERIA: All papers were published between 2000 and December 2014 and used the terms mucositis, chemotherapy, mouth rinses, oral care, oral care protocol, dental care, dental cleaning, oral decontamination, and oral hygiene. Both research and clinical work were included.
 
EXCLUSION CRITERIA: Review articles, clinical case reports, literature reviews, and other nonresearch articles were excluded. Articles not written in English also were excluded. 

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 151
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No evaluation method was identified.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 30
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not reported
  • KEY SAMPLE CHARACTERISTICS: Chlorhexidine, benzydamine, sodium bicarbonate, granulocyte macrophage colony-stimulating factor, iseganan, sucralfate, and normal saline were reviewed. No sample characteristics were reported.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics and palliative care

Results

None of the mouth rinses were definitely effective in preventing chemotherapy-induced oral mucositis in children. Normal saline had a preventive effect in patients receiving chemotherapy, radiotherapy, and hematopoietic stem cell transplantation, but other studies have shown less efficacy than chlorhexidine or honey with saline. Benzydamine was less effective than chlorhexidine.

Conclusions

There was limited evidence for agents to prevent or manage oral mucositis in children.

Limitations

  • Few studies for any single agent used
  • Few data bases used  
  • Limited sample information provided  
  • No quality of research evaluation

Nursing Implications

Mouth rinses are an important component to oral care in the prevention of mucositis in pediatric patients receiving chemotherapy. Nurses need to continue research to develop evidence-based practice guidelines for this debilitating side effect of chemotherapy.

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