The purpose of this study was to determine if a misoprostol oral rinse would reduce the severity of mucositis in patients receiving high-dose chemotherapy for autologous stem cell transplant.

This multi-center study employed a randomized, double blind, placebo controlled, parallel-group design. Participants were assigned to the misoprostol arm or placebo arm. Subjects swished and gargled the misoprostol or placebo solution (in 15 ml of water), held it in their mouths for 60 seconds, and then swallowed. Administration began 45 min. to 2 hours before the initiation of the conditioning regimen and then every 8 hours until 24 hours after the conditioning regimen was complete. All subjects also received instructions on standard care and instructed not to use other oral care for 1 hour after the misoprostol or placebo solution. The Oral Mucositis Index was used to grade mucositis every 2 to 3 days.

The study was comprised of 48 patients, 22 in treatment arm and 26 in placebo group, with an age greater than or equal to 18 years.
MALES 30%, FEMALES 70%
KEY DISEASE CHARACTERISTICS: Lymphoma, multiple myeloma, or solid tumor patient undergoing autologous stem cell transplant.
OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have been receiving cisplantin/carboplatin conditioning regimens or total body irradiation.

SITE: Multi-site

SETTING TYPE: Inpatient

LOCATION: Six participating sites in the United States

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care

Randomized, double-blind, placebo-controlled, parallel group design

• Modified Oral Mucositis Index
• Clinical examination by calibrated examiners
• Photographs
• Visual Analog Scale
• Pain Affect Faces Scale
• Length of hospital stay
• Days of parental nutrition

No statistically significant differences in Oral Mucositis Index scores. No statistically significant differences in the peak mucositis severity scores. No statistically significant differences in pain ratings, length of hospital stay, or days of total parenteral nutrition. There were no serious adverse events.

There was not a statistically significant benefit to using a misoprostol rinse in deterring the development or the severity of oral mucositis in patients undergoing autologous stem cell transplant. There was also no decrease in the length of stay or the use of total parenteral nutrition.

Small sample (<100)

Findings not generalizable

Other limitations/*explanation: The patient population was limited to only those cancer patients undergoing autologous stem cell transplant.

This study provides no evidence to support using a misoprostol mouth rinse to prevent the development of mucositis, decrease the severity of mucositis, decrease the length of stay, or decrease the use of total parenteral nutrition in patients undergoing a non-TBI based or non-cisplatin/carboplatin-based conditioning regimen for autologous stem cell transplant.

570 articles were included in this literature review. Literature contained prevention and/or treatment methods for mucositis. Interventions for treatment of mucositis were given, recommendations against an intervention were provided, suggestions in favor of an intervention were supplied, and suggestions against an intervention were given.

Recommendations included a combination of teeth brushing, flossing, mouth rinsing, and use of growth factors and cytokines in treatment of mucositis. The use of anti-inflammatory agents was also recommended. Low level laser therapy was recommended in prevention of mucositis with specific types of cancer treatment. Cryotherapy was also recommended for patients receiving chemotherapy. A list of natural and miscellaneous agents was recommended for treatment and prevention of mucositis.

Limitations of this study include clinical situations that were not seen in the literature review or that are rare in clinical settings. These limitations occur because of conflicting evidence or not enough evidence provided.

Nurses should be assessing patients' pain control, nutritional support, ability to eat, and oral hygiene practices, and should be teaching on the use of oral care products that are essential for prevention.

To investigate the effects of cyclooxygenase-2 (COX-2) inhibition on the severity and morbidity or oral mucositis in patients with head and neck cancer undergoing radiation based on the role of inflammatory pathways in oral mucositis pathogenesis

Patients were randomized using a one-to-one ratio in blocks of 10 to receive either celecoxib or a placebo. The celecoxib and placebo capsules were identical. The first four patients took 200 mg of celecoxib twice per day beginning five days prior to the first day of radiation therapy and continuing for three days after the conclusion of radiation therapy. Dosing was modified for all subsequent patients to 200 mg of oral celecoxib once per day only on the days of radiation therapy from the first to the last day of therapy. Subsequent patients assigned to the control arm took the placebo once per day for the same duration. Data were collected two to three times per week for the six to seven weeks during which radiation occurred.

• N = 40  
• AVERAGE AGE = 54.6 years 
• MALES: 32 (80%), FEMALES: 8 (20%)
• KEY DISEASE CHARACTERISTICS: Head and neck cancer

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Hartford Hospital (outpatient setting)

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care

Prospective, randomized, double-blinded, placebo-controlled, parallel-arm trial

• Oral Mucositis Assessment Scale (OMAS)
• World Health Organization (WHO) oral mucositis scale
• National Cancer Institute's Common Toxicity Criteria (NCI-CTC) Scale version 2
• Brief Pain Inventory (BPI)
• Performance Status Scale (PSS)
• Advanced opioid converter

There was no difference in oral mucositis severity between the celecoxib and placebo groups (p = .67).

The use of a COX-2 inhibitor during radiation in patients with head and neck cancer did not reduce the severity of clinical oral mucositis, mouth pain, dietary compromise, or use of opioid analgesics. This study’s power calculation seems to be weak. The dropout and missing data rate (usually 20%) should be added to satisfy the original power calculation. This increases the significant risk of type II error. Without a study with a larger sample size, this practice cannot be recommended.

• Small sample (< 100)
• Risk of bias (sample characteristics): This study has a significant discrepancy for gender distribution. The study was predominantly male patients.
• Other limitations/explanation: The researchers note that because most of the subjects were on high doses of opioids, the small analgesic effect of 200 mg celecoxib daily may not have been enough of a dose to appreciate a response. They do mention that the four subjects that were on higher-dose therapy (celecoxib 200 mg BID) did not discern any effect on oral mucositis.

This is not an effective option for treating radiation-induced mucositis.

The study focused on the secondary prevention of febrile neutropenia with G-CSF and antibiotics.

G-CSF (5 mcg/kg subcutaneous) or G-CSF with antibiotics (ciprofloxacin 500 mg by mouth every eight hours and amoxicillin 500 mg by mouth or clavulanate 125 mg by mouth every eight hours) daily starting 48 hours after chemotherapy and continuing until the absolute neutrophil count is greater than 2,000 cells/mm³. Patients were included in the study for one treatment cycle.
 

• The 48 eligible patients were adults who received chemotherapy for solid tumors and had experienced a prior episode of febrile neutropenia.
• Patients were scheduled to continue on the same regimen without dose reduction.
• Most patients were receiving treatment for breast, ovarian, or lung cancer.

Two sites in Europe.

Prospective, randomized pilot trial.

Patients were evaluated with:

• Regular complete blood counts
• Temperature monitoring once daily
• Observation for adverse effects of the prophylactic antibiotics.

In the event of a fever, the antibiotic prophylaxis was discontinued and a complete clinical evaluation for infection was completed.

No episodes of febrile neutropenia occurred in the G-CSF group, and only one incident of febrile neutropenia was reported in the combined group (p = 1). Reported side effects were similar and mild.

G-CSF reduced the risk of febrile neutropenia recurrence. Antibiotics did not provide any additional benefit in terms of prophylaxis.

• Not placebo controlled, not blinded.
• Patients were not stratified, and the groups were not balanced, particularly by disease and the number of prior chemotherapy cycles.
• The study was inadequately powered, since the frequency of the outcome measure was close to none (febrile neutropenia episodes).
• Cost implications were discussed but not in detail.

To evaluate the effect of omitting day 2 administration of granisetron in the treatment of chemotherapy-induced nausea and vomiting (CINV)

• All patients received 16 mg IV ondansetron, 20 mg dexamethasone, and 50 mg ranitidine before highly or moderately emetogenic chemotherapy on day 1.
• On day 2, all patients received 10 mg metoclopramide, every 8 hours on days 2, 3, and 4; 8 mg dexamethasone daily on days 2 and 3; and 150 mg ranitidine every 12 hours.
• Patients were randomly assigned to receive either 0.5 mg granisetron on days 2 and 3 or placebo instead of granisetron on day 2 and 0.5 mg granisetron on days 3 and 4.
• Patients recorded emetic episodes and side effects of antiemetic medications in self-report diaries, which were evaluated on day 6.

• The study consisted of 73 participants.
• Mean age was 51.4 years.
• The majority (94%) of patients were female.
• The majority (95%) of patients had breast cancer.
• The majority were receiving chemotherapy containing 60 mg/m² doxorubicin.
• Nearly half (49%) of patients had previously experienced complete protection in the first cycle of chemotherapy at baseline.

The study was conducted at a single outpatient setting in Brazil.

All patients were in active treatment.

This was a randomized, placebo-controlled, double-blind trial.

• Emesis was measured using the Functional Living Index-Emesis (FLIE).
• Complete protection was defined as absence of any episode of nausea or vomiting.

• A higher proportion of patients in the experimental group experienced complete protection from nausea and vomiting (p = 0.046) in the acute phase.
• No significant differences were found between groups in FLIE scores or proportions of patients who achieved complete protection from nausea and vomiting in other treatment phases.
• No differences were found between groups in adverse events.

Differences in rates of complete protection from nausea and vomiting in this study were unclear and difficult to interpret because different groups experienced better CINV control at different time points.

• The sample had fewer than 100 participants.
• Although the authors concluded that elimination of one dose of granisetron resulted in better control, the actual results reported did not appear to support that conclusion.
• It was also unclear how the two groups truly differed, other than the timing of the medication, because the “control” group received granisetron on the same number of days in the treatment cycle.
• Measurement depended on patient diaries; however, overall compliance rate with diaries was not reported.
• Statistical significance was not seen, despite power analysis that demonstrated a sufficient sample size to demonstrate a 35% difference in complete protection rates.
• Because the study sample was predominantly female, the ability to generalize is questionable.

No clear conclusions can be drawn from this study.

To evaluate whether skipping day 2 antiemetic medications may improve delayed chemotherapy-induced nausea and vomiting (CINV), based on the hypothesis that repeated consecutive doses of antiemetics may lead to increased accumulation of 5-HT₃ at the presynaptic level in the gastrointestinal (GI) tract, decreasing the activity of the next dose of a 5-HT₃ receptor antagonist (tachyphylaxis)

Patients were given day 1 antiemetics according to American Society of Clinical Oncology (ASCO) guidelines. Patients in Study 1 received 10 mg metochlopramide by mouth every eight hours, 0.05 mg granisetron by mouth four times per day, and 8 mg dexamethasone four times per day on days 2 and 3. In Study 2, patients received the same medications except that no drugs were given on day 2. Patients recorded emetic episodes in diaries and responded to a quality-of-life (QOL) questionnaire at baseline and on day 6.

• The study consisted of 42 chemotherapy-naïve patients over age 18 who were receiving moderately to highly emetogenic chemotherapy (MEC to HEC).
• Patients were excluded from the study if they had abnormally high serum creatinine, bilirubin, or SGPT; if they were pregnant; if they reported vomiting or use of antiemetics 24 hours before the administration of chemotherapy; or if they were receiving radiation therapy. Patients with brain metastasis, GI obstruction, or regular use of corticosteroids or benzodiazepines before the initiation of chemotherapy also were excluded.

The studies were conducted in the hematology and oncology department of a School of Medicine in Brazil.

This research consisted of two pilot studies.

The Functional Living Index of Vomiting (FLIE) was used.

• Each study consisted of 21 patients. No significant differences were found between the two populations in terms of clinical characteristics or chemotherapy emetogenicity.
• Patients who received no antiemetic medications on day 2 had statistically significant complete control of their nausea and vomiting.

Skipping day 2 antiemetic medications does not seem to worsen delayed CINV and may reduce CINV.

Study limitations include the use of a nonrandomized design and the small sample size.

The objective of the study was to investigate the effect of guided imagery with theta music on dyspnea in patients with advanced cancer.

The intervention consisted of four periods.

• Three minutes resting quietly with no stimulation
• Four minutes of “control” (non-theta) music listening
• Guided imagery segment, consisting of three minutes of theta music only, followed by four minutes of theta music plus imagery instruction, followed by three minutes of theta music only
• Three minutes resting quietly with no stimulation.

Theta music was provided by a recording designed to stimulate brain waves in the theta range of 4–8 Hz. Music was provided by a standard audio CD with headphones. Dyspnea rating was done in the first and last periods of the intervention, while resting quietly. Physiologic parameters of respiratory rate, heart rate, end tidal CO₂, and pulse oxygen saturation were collected at each of the four segments of the intervention. Physiologic parameters were continuously measured using a Tidal Wave 715 capnograph/pulse oximeter, using a finger probe. Patients were interviewed at the end of the session via open-ended questions to elicit how they felt.

• The study reported on a sample of 53 participants.
• The mean age was 58 years (SD = 16.2 years).
• Of the sample, 58.5% were males and 41.5% were females.    
• Of the sample, 37.7% had lung cancer and the rest had other types of cancers.
• All had Borg scale scores greater than or equal to 5. 
• Of the sample, 54.7% were on oxygen therapy and 32.1% were on medication for dyspnea.
• Medications used are not described.
• Of the sample, 58.5% had secondary or higher-level education.
   

The study was conducted in a multi-site, inpatient setting in Taiwan.

• Patients were undergoing end-of-life care.
• The study has clinical applicability for late effects and survivorship and end-of-life and palliative care.
   

Single group repeated measures

• Modified Borg scale    
• Physiologic parameters via continuous pulse capnograph/eximeter
   

• The mean modified Borg scale score improved significantly with the intervention, with a baseline mean score of 5.9 and post-intervention score of 3.2 (p = .000). 
• Ninety percent of subjects said they felt that the intervention had benefited them, indicating they felt “refreshed\" or “comfortable and peaceful,\" and 57% fell asleep during the intervention. 
• Statistically significant declines were seen in heart rate (pre: 96.3 bt/min, post: 94.9 bt/min, p = .005) and respiratory rate (pre: 20.4/min, post: 18.9/min, p = .000). 
• No significant difference was seen in oxygen saturation. 
• End tidal CO₂  increased significantly from 28.5 pre-intervention to 29.1 post-intervention.
• Post hoc testing showed that CO₂ increased most with the combined guided imagery and theta music. 
• Subjects showed decline in heart and respiratory rates throughout all parts of the session.

Findings support the hypothesis that subjects who receive the guided imagery and theta music intervention experience reduction in heart and respiratory rate and subjective intensity of dyspnea.

• The study had a small sample size of less than 100.
• Although no control group was used for comparison, the repeated measures design did allow for comparison of physiologic parameters at various time points. 
• No analysis was done of differences between those on oxygen and those not, in terms of physiologic response. 
• Although changes in heart and respiratory rates were statistically significant, the level of the change does not suggest clinical significance of these changes. 
• Of an initial sample of 69 patients, 16 said they could not concentrate to complete the guided imagery. Analysis showed that these patients had significantly less formal education than others, suggesting that such factors may influence results. 
• The measures were short-term, so any more lasting effects on symptoms are not known. 
• Because the intervention was combined, what effects imagery versus the theta music itself had is not clear.
   

• Findings suggest that guided imagery and listening to theta music can be beneficial for patients with dyspnea.
• This appears to be a practical intervention. 
• Further research in this area is warranted to determine most effective “dosing” and timing of such an intervention and to further explore the relevance of education level to ability to participate fully in guided imagery. 
• Because most patients fell asleep during this intervention, the effect of this type of intervention to manage sleep disturbance may be useful as well.

To evaluate the effectiveness of aroma massage in the treatment of constipation, as well as its impact on quality of life (QOL).

Patients were randomized to one of three groups: aroma abdominal massage, plain abdominal massage, or control. Fifteen- to 20-minute massages were offered daily for five consecutive days by the principal investigator and four other trained investigators. Patients completed questionnaires on days 1 and 5. Patients were withdrawn from the study if they required increased use of laxatives, had symptoms such as shortness of breath or fatigue, or were transferred or discharged from the hospital.

• The study reported on a sample of 32 patients.
• Patient age ranged from 32 to 82 years. Most patients were aged 51 to 60 years.
• The sample was 75% male and 25% female.   
• Most patients (56%) had lung cancer.
• Karnofsky performance scale index ranged from 40 to 80. Most patients' scores were from 40 to 50.

• Single site
• Inpatient
• Hong Kong
   

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

This was a randomized controlled trial.

• Constipation Assessment Scale (CAS)    
• McGill Quality of Life questionnaire for Hong Kong Chinese (MQOL-HK)

• In the aroma massage group, constipation improved with a mean score of 1.46 at day 5 compared to mean scores of 1.55 in the plain massage group and 6.63 in the control group.
• Patients in the aroma massage group reported improved physical domain, more support, and generally improved QOL compared to the other groups.

Constipation is a common, preventable problem in patients with cancer. Nurses should have knowledge of alternative nonpharmacologic approaches to help patients manage this side effect.

• The sample size was small (fewer than 100).
• Generalizability of the results is limited bcause of the small sample size. In addition, too many patients withdrew from the control group to draw an accurate conclusion.

Nurses play a vital role in the treatment and prevention of constipation.

To compare the effects of music intervention with nursing presence (MINP) and the effects of recorded music (RM) on various psychological and physiologic indices among caregivers of patients with cancer. The recorded indices included the incidence of depression and anxiety, sleep, blood volume pulse (BVP) amplitude, and the low/high frequency ratio component of heart rate variability (HRV).

Participants were seated on a comfortable chair in their own homes. A photoplethysmograph was worn on the left-hand middle finger to continuously monitor BVP amplitude and HRV.

The intervention groups were MINP versus RM. Interventions were alternated between MINP and RM with an interval of one week between each intervention. Each intervention took place in the participant’s home for 30 minutes and generally after dinner according to participant preference. In the MINP intervention, participants were told to imagine they were attending a concert. During MINP, the primary researcher was present and played music on the erhu (Chinese violin) and recorder without any verbal communication or interruption. The live music included diverse pieces such as Japanese, Chinese, Taiwanese, English, and Czech music. Music selections were well known by participants and expected to create immediate enjoyment, and all had similar musical characteristics and quality. Rhythm ranged from 60–80 beats, and the tempo was slow. In the RM intervention, participants were left alone to listen to 30 minutes of the same music selections prerecorded on a CD. The music volume was adjusted to a comfortable level before the session. Study measurement was obtained pre and post each intervention.

• The sample was comprised of 34 female caregivers of patients with cancer.
• Caregiver mean age was 44.9 years (SD = 9.03).
• Caregivers cared for patients with head and neck, lung, hematologic, gastrointestinal, or genitourinary cancers.
• Caregivers' relationship to the patient was 38% spouse, 38% parent, and 23% child.
• The majority of the sample had completed high school, were married, were employed, liked live music, and did not play a musical instrument.

• Outpatient
• Home setting
• Taiwan, Republic of China

• Transition phase (patients diagnosed with cancer less than one year ago)
• Late effects/survivorship; anxiety; nursing presence

A randomized, crossover, controlled trial design was used.

• Visual analog scale (VAS): Sleep assessment measured (a) ease of getting to sleep, (b) perceived quality of sleep, (c) ease of awakening from sleep, and (d) daytime function. No reliability or validity information was provided.    
• Taiwanese Depression Scale: Has criterion-related validity with the Center for Epidemiologic Studies–Depression scale and discriminate validity (93.2%); Cronbach’s alpha for the current study at pretest was 0.73. 
• State-Trait Anxiety Inventory: Cronbach’s alpha for the current study was 0.78.
• BVP amplitude
• Low frequency (LF)/high frequency (HF) ratio
• VAS was also used to assess music evaluation of participants’ subjective experience associated with the musical pieces (i.e., enjoyment, harmony, friendliness, and peacefulness); two-week test-retest reliability in an earlier study was 0.73.

Both MINP and RM interventions had significant beneficial effects on anxiety, depression, and BVP amplitude (p < 0.0001). A treatment effect across different time points was observed in BVP amplitude and LF/HF ratio in both groups, indicating that MINP and RM both have beneficial effects on BVP and LF/HF ratio. There were no significant differences between the two music interventions in terms of participant evaluation of enjoyment and peacefulness, but participants evaluated RM as being more harmonious than live music, and MINP with live music and nurse presence as more friendly. Participants preferred Chinese music, then followed mostly by Czech music. Regarding the four aspects of sleep measured, MINP was found to affect only \"ease of getting to sleep” (p < 0.0007).

Both music interventions were beneficial on psychological indices, with a reduction in anxiety and depression scores and a long-term dose effect on BVP. Intervention worked well for a sample having moderate degrees of anxiety and, in some cases, clinical depression in prestudy assessment and for a sample of women who liked Chinese and folk music.

• The sample was small, limiting generalizability. 
• The study had no researcher blinding.
• The study had single time point pre/post measures and was short-term (no range follow-up or impact).
• The sample was all female.
• The sample enjoyed the music used in the intervention and scored high on a pretest self-rated anxiety scale to increase receptivity to the intervention.

Music, either live with the nurse present or recorded for 30 minutes, may be beneficial in reducing anxiety and depression in women with cancer as well as their caregivers. Nurses can encourage the use of music as a way of reducing stress throughout the cancer journey. Listening to music appreciated by the caregiver may enhance coping early in the caregiving cycle and prevent negative effects during challenges of cancer treatment and survivorship. Music prescription is an inexpensive intervention and useful for caregivers who prioritize music as part of their culture.

STUDY PURPOSE: To evaluate skin antisepsis in reducing catheter-related bloodstream infections (BSIs), catheter colonization, morbidities, and mortality

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 12 studies included in meta-analysis 
• TOTAL PATIENTS INCLUDED IN REVIEW: 2,011
• SAMPLE RANGE ACROSS STUDIES: 50–420
• KEY SAMPLE CHARACTERISTICS: Included studies in pediatric patients. Most studies included patients in intensive care units.

PHASE OF CARE: Not specified or not applicable

Analysis of chlorhexidine versus povidone iodine showed a relative risk of 0.064 (p = 0.05) in favor of chlorhexidine for the outcome of BSI. No significant difference existed between these two methods for all-cause mortality. Chlorhexidine was associated with less catheter colonization (RR = –0.08, p = 0.0003). Few studies compared the use of alcohol, octenidine, hydrogen peroxide, and silver.

The findings suggest that skin antisepsis with chlorhexidine is most effective in reducing BSI; however, the overall quality of the evidence is very low to moderate.

Mostly low quality/high risk of bias studies

Chlorhexidine is generally more effective than povidone iodine or alcohol for skin antisepsis as part of catheter care for reducing catheter-related BSIs and catheter colonization.