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Li, X.M., Yan, H., Zhou, K.N., Dang, S.N., Wang, D.L., & Zhang, Y.P. (2011). Effects of music therapy on pain among female breast cancer patients after radical mastectomy: Results from a randomized controlled trial. Breast Cancer Research and Treatment, 128(2), 411–419.

Study Purpose

To explore the effects of music on pain, in patients with breast cancer, after radical mastectomy  

Intervention Characteristics/Basic Study Process

The intervention group consisted of 60 patients who received MP3 players with headphones. The players were loaded with 202 selections of music; the music was of four types. Patients were instructed to listen to music, during the postoperative period and two chemotherapy periods (18.9 days, SD = 7.1 days), for 30 minutes twice a day, between 6 and 8 a.m. and between 9 and 11 p.m. While patients were in the hospital, a researcher encouraged adherence to the schedule. After the patients were discharged, a researcher used the telephone to encourage adherence. The control group consisted of 60 patients who were not blinded regarding the music intervention. All patients took four tests (one at baseline and three postrandomization). Pain levels were assessed before the surgery, on the first preoperative day; on the day before disharge; and upon admission for the first and second chemotherapy sessions. Cycle lengths for chemotherapy were 14, 21, or 28 days. The assesment one day prior to discharge was known as the first post-test. The assesments before the chemotherapy sessions were known as the second and third post-tests, respectively.

 

Sample Characteristics

  • The sample was composed of 120 breast cancer patients.
  • The age range of patients was 25–65 years.
  • All patients were female.
  • All patients had breast cancer and underwent radical, modified radical, or extensive radical mastectomy. All patients received patient-controlled analgesia following surgery.

Setting

  • Single site
  • Inpatient
  • Surgical department of oncology center, First Affiliated Hospital of Xi’an, Jiaotong University, Shanghai
     

Phase of Care and Clinical Applications

Clinical applications: late effects and survivorship

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • General questionnaire    
  • Chinese version of Short-Form McGill Pain Questionnaire (which included a visual analog scale, VAS, and a measure of present pain intensity, PPI)
  • Pain Rating Index

Results

Both groups reported improvement in all areas of assessment from baseline through the third post-test. At the first post-test (day prior to discharge), the difference between the two groups was –2.38% in favor of music (p < 0.05). By the third post-test, the differences had decreased to –1.87 (p < 0.05).

Conclusions

Findings show that listening to music was associated with reduction in pain severity.

Limitations

  • The report provided no information regarding the use or nonuse of any form of analgesia in the postoperative period and during chemotherapy. 
  • Limitations outlined by the authors include an assessment procedure that depended on self-reporting, which is affected by many factors; the use of quantitative research only; the lack of biomarkers or physiological measurements; the fact that the assessor was not blinded to patient assignment to intervention or control group; and risk of bias due to no attentional control condition.

Nursing Implications

This study should be refined to determine and differentiate types and quality of pain and to consider the fact that pain typically decreases during the postoperative period. The differences noted between groups may indicate that music could play a role in reducing the pain that patients experience in the period immediately following surgery.

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Li, M., Kennedy, E.B., Byrne, N., Gerin-Lajoie, C., Katz, M.R., Keshavarz, H., . . . Green, E. (2016). Management of depression in patients with cancer: A clinical practice guideline. Journal of Oncology Practice, 12, 747–756. 

Purpose & Patient Population

PURPOSE: This is an update of a previously published guideline that provided recommendations for the management of depression in adult patients with cancer.
 
TYPES OF PATIENTS ADDRESSED: Patients with cancer at various stages of treatment with suspected or diagnosed major depressive disorder

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: A working group that involved experts in nursing, health research methodology, psychiatry, and psychology conducted the review. The project methodologist extracted data, and the project research assistant verified the data. The draft recommendations were reviewed by a panel of internal reviewers and external reviewers. Targeted peer review and professional consultation were also obtained, and the results were incorporated into the final guideline.
 
SEARCH STRATEGY: Search terms related to depression and cancer were used.
 
DATABASES USED: Websites of guideline developers, relevant cancer agencies, MEDLINE, and EMBASE
 
INCLUSION CRITERIA: Systematic reviews of randomized, controlled trials (RCTs) or single RCTs in the English language
 
EXCLUSION CRITERIA: Not mentioned

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference

Several clinical practice guidelines and two meta-analyses of 21 RCTs and some integrative reviews were included. Guideline quality was assessed with the AGREE II instrument, and a systematic review quality was assessed with the Assessment of Multiple Systematic Reviews (AMSTAR) tool.

Guidelines & Recommendations

Evidence synthesis resulted in eight recommendations for the management of depression: 
  • Screening of patients with cancer for depression is very important to guide treatment.
  • Psychoeducation and providing information about the nature of depression and its impact in cancer outcomes are important. Optimizing cancer-related symptom management
  • Pharmacologic or psychosocial interventions either alone or in combination have beneficial effects.
  • A stepped care model that suggests low intensity interventions (i.e., physical activity programs, group-based peer support, and self-help programs) for mild -to-moderate depression and high-intensity interventions (i.e., group cognitive behavioral therapy, behavioral couples’ therapy, and individual or group supportive-expressive psychotherapies) for severe depression were recommended.
  • Collaborative care (active collaboration between the oncologist or primary care provider and a patient care manager nurse, social worker, or psychologist) should be considered.
  • Referral to psychosocial specialist when needed
  • Selection of psychological therapy should be based on patient factors and local resource availability. This recommendation is based in consensus. 
  • Antidepressants should be considered for severe depression, not for mild depression related to high risk–benefit ratio.

Limitations

Some recommendations were consensus-based.

Nursing Implications

A quick reference algorithm for the initial management of depression in patients with cancer and the stepped care model for delivering care interventions depending on the severity of depression are great tools nurses and other healthcare professionals can use in their clinical practice while managing depression.

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Li, L., Yuan, L., Chen, X., Wang, Q., Tian, J., Yang, K., & Zhou, E. (2016). Current treatments for breast cancer-related lymphoedema: A systematic review. Asian Pacific Journal of Cancer Prevention, 17, 4875–4883. 

Purpose

STUDY PURPOSE: To summarize the effects of different breast cancer–related lymphedema (BCRL) treatments

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Cochrane, PubMed, EMBASE, ISI Web of Knowledge
 
YEARS INCLUDED: Inception–December 31, 2015
 
INCLUSION CRITERIA: Systematic review or meta-analysis for BCRL
 
EXCLUSION CRITERIA: Duplications, non–meta-analyses, nontreatment, traditional reviews

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,740
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two investigators independently reviewed the studies and used the GRADE approach, specifying four levels of quality. All evidence was deemed low or very low quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 14
  • TOTAL PATIENTS INCLUDED IN REVIEW: Unknown
  • SAMPLE RANGE ACROSS STUDIES: Complex decongestive therapy (CDT), manual lymphatic drainage (MLD), intermittent pneumatic compression, exercise, botanicals, low-level laser therapy (LLLT), surgery, weight reduction, stem cells, Kinesio Tex Tape (KTT), acupuncture

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Results

  • CDT needs comparisons.
  • MLD was deemed safe (60%–80% of participants reported feeling better). 
  • Exercise appeared to have no effect on lymphedema.
  • Insufficient evidence for the use of botanicals
  • LLLT demonstrated greater reductions, but sample sizes were small (8–64), for a total of 289.
  • Modern surgery has a role in management.
  • KTT is no more effective than usual care.
  • Acupuncture appears to be safe but lacks evidence.

Conclusions

Based on the study limitations, the most effective treatment for BCRL could not be identified, because of varying quality and small sample sizes with high risk of bias. Different treatments for BCRL might reduce volume, but effects and well designed randomized, controlled trials with reported placebo effects are needed.

Limitations

  • Mostly low quality/high risk of bias studies
  • Low sample sizes
  • This review lacked a large number of studies in all the interventions reviewed.

Nursing Implications

CDT remains the standard of care for the treatment of lymphedema. Complementary therapies may be safe, but more well designed randomized, controlled trials are needed.

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Livingston, P.M., Craike, M.J., Salmon, J., Courneya, K.S., Gaskin, C.J., Fraser, S.F., . . . ENGAGE Uro-Oncology Clinicians' Group. (2015). Effects of a clinician referral and exercise program for men who have completed active treatment for prostate cancer: A multicenter cluster randomized controlled trial (ENGAGE). Cancer, 121, 2646–2654. 

Study Purpose

To determine the effectiveness of referrals from nurses or medical providers to a 12-week exercise program compared to usual care for the outcome of self-reported physical activity among men after completion of active prostate cancer treatment.

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to the intervention or to the control: The intervention was a 12-week exercise program that included two gym sessions and one home-based session per week beginning 3–12 months after active treatment for prostate cancer was completed. Intervention participants were given a referral slip stating that the clinician recommended participation in the exercise program. The 12-week exercise program was at a local community gym, supervised by exercise physiologists, and followed exercise guidelines for cancer survivor exercises by the American College of Sports Medicine and the Exercise and Sport Science Australia. The exercise intervention also used social cognitive theory. The control group had usual care, which included a recommendation to exercise.

Sample Characteristics

  • N = 131  
  • MEAN AGE: 65 years (range = 39-84)
  • MALES: 100%  
  • KEY DISEASE CHARACTERISTICS: 3-12 months after completion of treatment with curative intent for prostate cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: A majority of participants had stage I (15%) or stage II (16.5%) prostate cancer, and there were no significant between-group differences except for the disease stage (p < 0.01) and treatment (p < 0.05) between groups. English language ability to read and complete surveys

Setting

  • SITE: Single site     
  • SETTING TYPE: Outpatient        
  • LOCATION: Melbourne, Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

  • Prospective, multicenter, cluster, randomized controlled trial with two arms

Measurement Instruments/Methods

  • Godin-Shepherd Leisure Time Exercise Questionnaire: A monthly self-report of number of minutes of moderate-to-vigorous physical activity in a typical week in the past month. Measures were zero minutes, light intensity, moderate intensity, vigorous intensity, and minutes greater than 150 per week, with definitions of each level.
  • ActiGraph for T1 (7 days at the baseline) and T2 (immediately after the 12-week exercise program) with the same time period of measures in the control group. Freedson adult cut points for light-intensity and average daily activity: used in the activity calculations but not reported. 
  • Quality of life: Measured by the European Organization for Research and Treatment of Cancer Quality-of-Life Core-30 questionnaire (QLQ-C30, which has a cognitive functioning subscale) and prostate tumor–specific module (QLQ-PR25). 
  • Prostate cancer–related anxiety: Memorial Anxiety Scale for Prostate Cancer (MAX-PC).
  • Depressive symptoms: 20-item Center for Epidemiological Studies-Depression Inventory, with mean and total scores calculated.
  • Satisfaction: Measured in the intervention group using a survey to assess the acceptability, convenience, and feasibility of the clinician referral and exercise program. 

Results

Intervention participants indicated positive reports about clinician referral influencing participation in the exercise program.  Prostate cancer-related anxiety declined more in the control group (d = 0.42, p = 0.02).  Effects on depression were not significant, but there was greater decline in the intervention group (d = -0.35, p = 0.06). There was no significant change in the cognitive subscale of the QOL measure. A higher percentage of those in the intervention group reported achievement of aerobic exercise guidelines.

Conclusions

Clinician referral from doctor or nurse care provider influences decision to participate in a tailored exercise program among men who have completed prostate cancer treatment. Exercise program supervision helps to ensure that exercise is tailored to each individual, risk of injury is reduced, and potential for adherence is improved.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Activity level may have been higher at baseline due to time after completion of treatment; activity measures may not have been as accurate as desired or may have been worn at different times than desired.

Nursing Implications

Nurse clinicians may influence participation in an exercise program for men who have completed radiation, chemotherapy, or surgery for prostate cancer, touting benefits of improved physical activity, cognition, QOL, and other health outcomes, including significant reduction of anxiety self-report and moderate reduction of depression symptoms. A specific referral or prescription for exercise may enhance exercise participation and activity that meets current national recommendations.

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Liu, Y., Zhang, J., Teng, Y., Zhang, L., Yu, P., Jin, B., … Li, Z. (2009). Thalidomide improves prevention of chemotherapy-induced gastrointestinal side effects following a modified FOLFOX7 regimen: Results of a prospective randomized crossover study. Tumori, 95, 691–696.

Study Purpose

To evaluate the safety and effectiveness of thalidomide plus ramosetron and dexamethasone in controlling delayed chemotherapy-induced GI side effects following a moderately emetogenic FOLFOX7 regimen 

Intervention Characteristics/Basic Study Process

Patients who were chemotherapy-naïve and scheduled to receive a moderately emetogenic FOLFOX7 regimen were randomized to two groups. Group A-B received ramosetron plus dexamethasone on day 1 in the first cycle. Group B received thalidomide twice a day on days 2-5 in cycle 1. Group B-A received the same drugs in reverse sequence.

All patients received ramosetron. All patients were permitted to receive a rescue dose of 10 mg dexamethasone IV if vomiting occurred more than two times within 24 hours.

Sample Characteristics

  • The study consisted of 52 patients.
  • Patient ages ranged from 18–70 years. The median age in group AB was 55.5 years, and the median age in group BA was 54 years.
  • The sample was 33% female and 67% male.
  • Cancer diagnoses were gastric (40%), colorectal (52%), and other (8%).
  • Just over half (52%) of patients had a European Cooperative Oncology Group (ECOG) performance status of 0, and the balance (48%) had an ECOG performance status of 1.

Setting

The study was conducted at a single site at the China Medical University in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a prospective, randomized, crossover-controlled study.

Measurement Instruments/Methods

  • For five days, patients recorded any episodes of vomiting and the degree of nausea and anorexia as well as peripheral neuropathy, sedation, hot flushes, headache, dry mouth, and rash. The article did not address where these effects were documented.
  • Side effects were graded with the Common Toxicity Criteria of Adverse Events, version 2.0 (CTAE v.2.0).

Results

  • Complete response rates (CRR) and effective rates (ER) for acute nausea were not different on day 1. However, they were statistically significant for delayed nausea on days 2-4 for group B. The CRR and ER for both groups on day five were similar and showed no significance (CRR: p = 0.309, ER: p = 0.050).
  • Efficacy for acute vomiting showed no significant difference between the groups. Group B's delayed vomiting rates were higher and statistically significant on days 2–3.
  • No significant differences in adverse events was noted.

Conclusions

Neither palonosetron or aprepitant are commercially available in China. Thalidomide was associated with greater complete response of delayed nausea and delayed emesis. No significant adverse effects were noted with thalidomide.

Limitations

  • The sample size was small with fewer than 100 participants.
  • No mention was made of how patients recorded their symptoms.
  • Confirmation of clinical value is warranted with a larger study.
  • The control group did not receive any placebo medication so patients knew when they were in the treatment phase because they received more medication; this may have biased the results.

Nursing Implications

Thalidomide has some efficacy in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving FOLFOX7 therapy in combination with other antiemetic regimens.

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Liu, C., Hsiung, P., Chang, K., Liu, Y., Wang, K., Hsiao, F., . . . Chan, C. (2008). A study on the efficacy of body-mind-spirit group therapy for patients with breast cancer. Journal of Clinical Nursing, 17, 2539–2549.

Study Purpose

To examine the effects of body-mind-spirit group therapy on anxiety, depression, and holistic well-being among women with breast cancer

Intervention Characteristics/Basic Study Process

Patients in the control group received standard care. Patients in the experimental group received standard care plus 10 sessions of weekly group therapy, 180 minutes per session. Therapy integrated concepts and practices, such as qigong exercises of vital energy, massage, meditation, positive thinking, group mutual support, long-term survivors’ sharing, songs, home assignments, and exercises. These activities were based on traditional Chinese medicine, the Eastern philosophies of Taoism and Confucianism, and the practice of Buddhism. The goal of the activities were to manage physical, psychosocial, and spiritual distress. Sessions included qigong exercises provided for 20 minutes each week by a qigong master and body-mind-spirit group assignments that included sharing and singing. The qigong master facilitated the first 20 minutes of each session. Then the primary investigator and co-investigators, working as mental health nurses, managed the rest of each session. Co-investigators held a 90-minute focus group interview after the last group therapy session. They conducted the interview in Mandarin and transcribed it. A bilingual researcher translated the transcription.

A coinvestigator implemented the randomization so that the patients, physician, and primary investigator were blinded to the randomization process. The primary investigator conducted groups after randomization and completion of initial surveys. Participants completed a baseline questionnaire after informed consent. After two months of intervention, participants completed a postintervention questionnaire.

Sample Characteristics

  • The sample was composed of 28 participants: 12 in the experimental group and 16 in the control group. 
  • Mean patient age in the study was 40–60 years. In the experimental group, mean patient age was 52 years (SD = 8.3 years). In the control group, mean patient age was 46.1 years (SD = 7.8 years).
  • The sample was composed of female patients with breast cancer only. Those suffering ailments in addition to breast cancer or receiving other psychotherapy were excluded.
  • Patients had cancer in stages I–III. The distribution of stages in groups follows: stage I, three patients in the experimental group and three in the control group; stage II, six patients in the experimental group and eight in the control group; stage III, two patients in the experimental group and three in the control group.
  • The types of surgery that patients had undergone included modified radical mastectomy, conservative surgery, and radical mastectomy, with the distribution of types in groups as follows: modified radical mastectomy, seven patients in the experimental group and nine in the control group; conservative surgery, three patients in the experimental group and five in the control group; radical mastectomy, two patients in the experimental group and two in the control group.
  • One patient in the experimental group and two patients in the control group experienced relapse.

Setting

  • Single site
  • Outpatient setting 
  • Consultation room of a cancer foundation center

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: late effects and survivorship

Study Design

Mixed-methods design incorporating a randomized controlled trial and focus-group interviews

Measurement Instruments/Methods

  • Beck Depression Inventory II (BDI-II)      
  • State-Trait Anxiety Inventory (STAI)
  • Body-Mind-Spirit Well-being Inventory (BMSWBI)

Results

  • Pre/post-test comparison of symptoms of depression in the intervention, or experimental, group and control group showed a difference in depression improvement and body-mind-spirit well-being; the difference was not significant.
  • Pre/post-test comparison of symptoms of anxiety in the intervention, or experimental, group and control group showed a significant difference (p < 0.03) in state anxiety.
  • Qualitative focus group interviews revealed eight domains with subthemes. The imparting information domain had seven themes: learning about appropriate diet, learning about treatment and care of breast cancer, learning how to monitor physical condition, learning to exercise, learning to practice relaxation, learning to reframe cognitive distress, and learning to practice forgiveness.
  • The interpersonal learning domain had two themes: having more interpersonal interactions and obtaining support from group members.
  • The catharsis domain had three themes: understanding the impact of suppressing emotions on holistic well-being, sharing suffering with group members, and learning to use projective methods to express emotions.
  • The universality domain had two themes: learning that I am not the only one who suffers from cancer and learning that personal characteristics are the common cause of cancer.
  • The domains of group cohesiveness and altruism each had one theme: having a sense of belonging and using one’s own successful experience to help others, respectively.
  • The existential factors domain had two themes: practicing self-love and learning to view misfortune positively.

Conclusions

Culturally sensitive body-mind-spirit group therapy reduced anxiety among outpatients with breast cancer.

Limitations

  • The study had a small sample, with fewer than 30 participants.
  • The researchers were not completely blinded to the randomization process because the coinvestigator implemented it.
  • Forty-nine participants were enrolled in the study, but only 28 completed the study. The drop-out rate reduces the power of the study.
  • Findings may have limited generalizability beyond women ages 40–60 with stage II breast cancer.
  • Longer-term follow-up to study maintenance of depression improvement are needed.

Nursing Implications

Mental health nurses who provide group therapy for patients with cancer could help to enhance quality of care in psycho-ontological nursing. Further research with older and younger women — as well as with patients in stages I, III, and relapse — are suggested.

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Liu, J., & Huang, X.E. (2014). Efficacy of bifidobacterium tetragenous viable bacteria tablets for cancer patients with functional constipation. Asian Pacific Journal of Cancer Prevention, 15, 10241–10244. 

Study Purpose

To determine the efficacy and tolerance of using a probiotic to treat functional constipation in patients receiving chemotherapy

Intervention Characteristics/Basic Study Process

All patients received chemotherapy appropriate for their diagnosis. Patients were divided into two groups. The treatment group received, in addition to chemotherapy, Bifidobacterium tetragenous viable bacteria tablets three times a day for four weeks.

Sample Characteristics

  • N = 100  
  • MEDIAN AGE = 61.1 years
  • MALES: 68%, FEMALES: 32%
  • KEY DISEASE CHARACTERISTICS: Gastric and colorectal cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: Overall Wexner score was between 0–10 (72%) and 11–20 (28%).

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: Jiangsu province, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Patients were divided into two groups, experimental and control.

Measurement Instruments/Methods

  • Wexner constipation scoring system

Results

There was significant improvement of functional constipation (p < 0.05) with the use of four Bifidobacterium tetragenous viable bacteria tablets.

Conclusions

Probiotics may be beneficial for some patients receiving chemotherapy who suffer from functional constipation.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • There was no postintervention Wexner scores listed, although the authors stated that there was improvement in bowel function.

Nursing Implications

Additional research on the use of probiotics and a variety of chemotherapy regimens in patients with functional constipation needs to be completed.

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Liu, M.Y., & Huang, X.E. (2015). Effects of analgecine on oxaliplatin-induced neurotoxicity in patients with gastrointestinal cancer. Asian Pacific Journal of Cancer Prevention, 16, 4465–4468. 

Study Purpose

To assess the safety and effectiveness of analgecine for the control of oxaliplatin-induced neurotoxicity

Intervention Characteristics/Basic Study Process

Patients scheduled to receive oxaliplatin as adjuvant or palliative therapy were divided into experimental and control groups. Neurotoxicity was measured at four and eight weeks/cycles. Timing and dosage of the experimental agent were not described.

Sample Characteristics

  • N = 82   
  • AGE = 72% were older than 50 years
  • MALES: 32.9%, FEMALES: 67.1%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All had either gastric or colorectal cancer. The majority had metastatic disease.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Parallel group trial

Measurement Instruments/Methods

Common Criteria Criteria for Adverse Events (CTCAE), version 3.0

Results

The occurrence rate of toxicity was lower in the experimental group at four (p = 0.043) and eight (p = 0.05) weeks, and those in the experimental group generally had lower grades of toxicity.

Conclusions

Analgecine may have some role as a neuroprotective agent for patients receiving oxaliplatin; however, well designed research is needed to explore this.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • It is unclear how individuals were assigned to study groups.
  • The intervention was not described.

Nursing Implications

There is very limited evidence for interventions that can prevent or reduce neurotoxic side effects of chemotherapy. Additional research for analgecine is needed to determine if it has any role in this area.

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Liu, H.J., Gao, X.Z., Liu, X.M., Xia, M., Li, W.Y., & Jin, Y. (2014). Effect of intrathecal dexmedetomidine on spinal morphine analgesia in patients with refractory cancer pain. Journal of Palliative Medicine, 17, 837–840. 

Study Purpose

To investigate the effects of intrathecal dexmedetomidine on analgesia receiving intrathecal morphine for refractory cancer-related pain

Intervention Characteristics/Basic Study Process

Patients were initially provided intrathecal morphine at 0.4 mg/ml at a continuous dose of 0.1 ml per hour, a bolus dose of 0.5 ml, and then pump parameters were adjusted if pain score were > 4 or more than eight bolus doses were needed on the previous day. An external catheter was connected to a computerized ambulatory delivery pump. Patients were monitored for seven days and then were crossed over to receive intrathecal morphine at the same initial dose plus dexmedetomidine at 1 mcg/ml in a continuous infusion for seven days. Daily average pain scores and other study measures were recorded at baseline and at the end of each seven-day study period.

Sample Characteristics

  • N = 24
  • AGE = 58 years (SD = 14 years)
  • MALES: 42%, FEMALES: 58%
  • KEY DISEASE CHARACTERISTICS: Various tumor types; all had pain scores > 6 and systemic opioid use of more than 200 mg per day or dose-limiting side effects; the majority had nociceptive pain

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: China

Phase of Care and Clinical Applications

  • PHASE OF CARE: End of life care
  • APPLICATIONS: Palliative care

Study Design

Double-blinded, crossover, randomized trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain intensity 
  • Number of bolus doses required
  • Numeric Rating Scale (NRS) for sleep deprivation

Results

Pain intensity and frequency declined significantly with intrathecal morphine (p < 0.05) and then declined more with the addition of dexmedetomidine (p < 0.05). Sleep deprivation was improved in the same pattern (p < 0.05). With morphine alone, daily morphine consumption was 7.9 mg (SD = 1.1) and bolus dose frequency was 6.9 (SD = 1.3). With the addition of dexmedetomidine, morphine consumption decreased to 5.3 mg (SD = 0.8), and the frequency of bolus doses decreased to 2.8 times (SD = 0.7). The most frequent side effects were nausea, vomiting, difficulty urinating, and somnolence. Constipation decreased from baseline.

Conclusions

The addition of intrathecal dexmedetomidine to morphine analgesia decreased morphine consumption and improved pain control in patients with refractory cancer-related pain.

Limitations

  • Small sample (< 100)

Nursing Implications

Dexmedetomidine is an alpha adrenergic receptor agonist that has sympatholytic, sedative, and analgesic effects. The findings of this study suggest that the addition of this medication to morphine analgesia administered intrathecally may improve pain control and reduce morphine consumption and the number of bolus doses needed for pain control. It also demonstrated sedative effects. Refractory pain can be very difficult to manage to achieve adequate pain control. The approach studied here may provide an option for the management of refractory pain. Additional studies are needed to fully establish the safety profile and efficacy of this treatment.

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Liu, J., Tan, L., Zhang, H., Li, H., Liu, X., Yan, Z., . . . Zhang, D. (2015). QoL evaluation of olanzapine for chemotherapy-induced nausea and vomiting comparing with 5-HT3 receptor antagonist. European Journal of Cancer Care, 24, 436–443. 

Study Purpose

To evaluate the effect of olanzapine on quality of life (QOL) during chemotherapy compared with a 5HT3 receptor antagonist

Intervention Characteristics/Basic Study Process

Patients receiving multiple different chemotherapy regimens were randomized to one of two groups. Group one received olanzapine 10 mg PO, azasetron 10mg IV, and dexamethasone 10 mg IV, followed by olanzapine 10 mg PO on days 2-5. The control group received azasetron 10 mg IV and dexamethasone 10 mg IV, followed by dexamethasone 10 mg IV on days 2-5. Use of breakthrough antiemetics was permitted based on clinical circumstances. It is not reported whether patients received one cycle only. Patients were not all chemotherapy naive, but this was not controlled in the sample description.

Sample Characteristics

  • N = 229  
  • AGE = 18-74 years
  • MALES: 65%-72%, FEMALES: 43%-49%
  • KEY DISEASE CHARACTERISTICS: lung, breast, colorectal, lymphoma, ovarian, stomach, esophageal, teratoma, thymus, oropharyngeal, cervical, gingival, melanoma, and glioblastoma. All patients were receiving moderately or highly emetogenic chemotherapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: normal CBC, LFTs, metabolic profile, normal cardiac function, EKG, performance status of 2 or better, no nausea preceding 24 hours. Multiple exclusion criteria.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Harbin Medical University, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized trial using random digits

Measurement Instruments/Methods

  • EORTC-QLQ C30 was measured on day 0 and 6. CINV was measured with Common Toxicity Criteria.

Results

There was no significant difference in acute CINV, but delayed CINV showed complete response rates of 76.85% in the olanzapine group and 46.2% in the 5HT3 group (p < 0.05). CINV was also better controlled in five days post chemotherapy, with 85.95% in the olanzapine arm and 67.59% in the control arm. Not all patients completed QOL. Global health status, emotional functioning, social functioning, fatigue, CINV, and insomnia were improved in the olanzapine group. Pain and dyspnea improved in both groups.

Conclusions

CINV influences QOL for patients undergoing chemotherapy. Although olanzapine did not change CINV in the acute phase, it showed significance in the delayed CINV group. This demonstrated improvements in global health status, fatigue, and insomnia. 5HT3 antagonists were effective against acute CINV but not effective in delayed CINV.

Limitations

  • Risk of bias (no blinding)
  • Other limitations/explanation: The authors did not identify any limitations. All data comparisons were not identified. Description of prior treatments for patients were not listed. No subgroup analysis was completed between those receiving MEC and HEC regimens. No information was provided regarding use of other antiemetics as allowed in the study protocol

Nursing Implications

Olanazapine offers another option for treatment of CINV. Other symptoms may also be controlled with this medication, such as insomnia, appetite loss, fatigue, and global health status. Nurses can consider this when standard medications are ineffective.

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