To evaluate the efficacy of tropisetron in treating acute vomiting among children with solid tumors receiving chemotherapy

Tropisetron (5 mg for patients < 20 kg and 10 mg for patients > 20 kg) was given intravenously daily over 15 minutes 30 minutes before chemotherapy administration. No other antiemetics were given except for steroids in three patients with Hodgkin lymphoma and two patients with non-Hodgkin lymphoma. Data were collected hourly in the first 24 hours following chemotherapy.

• N = 50   
• MEDIAN AGE = 5.8 years (range = 6 months to 19 years)
• MALES: 27 (54%), FEMALES: 23 (46%)
• KEY DISEASE CHARACTERISTICS: Central nervous system tumor, retinoblastoma, neuroblastoma, and chondrosarcoma (n = 30); Wilms tumor (n = 7); rhabdomyosarcoma (n = 4); Hodgkin disease (n = 3); non-Hodgkin lymphoma (n = 2); Ewing sarcoma (n = 2); and hepatoblastoma (n = 2)
• OTHER KEY SAMPLE CHARACTERISTICS: All patients received either moderately or highly emetogenic chemotherapy.

• SITE: Not stated
• SETTING TYPE: Not specified    
• LOCATION: Not reported

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Descriptive

• Antiemetic effects were monitored by nurses and patients.
• Effects were classified as total control (TC, absence of acute vomiting), major control (MC, one to two acute vomiting episodes), or no control (NC, three or more acute vomiting episodes). 

Overall frequency: TC was obtained in 154 out of 189 chemotherapy courses (85%), MC in 7.5% of courses, and NC in 7.5% of courses.

Dosage: Patients who received greater than 8 mg/m² of tropisetron achieved TC significantly more often (92%) than patients receiving 6–8 mg/m² of tropisetron (78%) or 6 mg/m² (69%) (p = 0.0072).

Emetic potential: TC was achieved in 85% of patients receiving highly emetic chemotherapy, 81% of patients receiving moderately emetic chemotherapy, and 100% of patients receiving slightly emetic chemotherapy. NC was achieved in 6% of patients receiving highly emetic chemotherapy and 12% of patients receiving moderately emetic chemotherapy.  

Time of administration: TC was achieved in 91% of patients with initial chemotherapy while TC was achieved in 81% of patients who received an antiemetic medication for earlier chemotherapy (p > 0.05).

Age: The youngest age group (aged 0–5 years) achieved TC and MC 98% of the time while children aged 6–10 years achieved TC and MC 90.5% of the time and children aged greater than 10 years achieved TC and MC 84% of the time (p = 0.0235). Side effects of acute vomiting occurred immediately at the start of chemotherapy among one patient receiving tropisetron at 13.5 mg/m². 

Tropisetron was an effective antiemetic medication for pediatric patients receiving highly emetic chemotherapy. It was mostly effective for patients receiving moderately emetic chemotherapy. The medication was more effective in younger children (aged 0–5 years). The dosage should range from 8–12 mg/m² and be used with the initial chemotherapy course.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described

Tropisetron was an effective antiemetic medication that should be administered prior to the initial chemotherapy course.

To detect the optimal timing for the initiation of an exercise training intervention

This was a 12-week lifestyle intervention consisting of five components: physician referral and clinic support, health education, behavior change support, social support through group-based settings, and an individualized exercise program based on patient need. Patients were asked to attend exercise sessions twice a week with additional at-home implementation of the exercise regimen twice more per week. The individualized exercise programs consisted of progressive resistance-training programs with a short, moderate intensity warm-up followed by two sets of 8 repetitions for 10 exercises. Progression of the regimen occurred at weeks 4, 6, and 9, as appropriate. In addition to attending the exercise sessions, participants were required to attend six education sessions after their exercise sessions.

• N = 60   
• AGE = 56.1 years (SD = 9.2 years)
• MALES: 81.7%, FEMALES: 20.3%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Head and neck cancer

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: University of Calgary

PHASE OF CARE: Multiple phases of care

The study design is a randomized, controlled exercise trial in which patients were randomly assigned to either the immediate lifestyle intervention (ILI) group or the delayed lifestyle intervention (DLI) group.

• Godin Leisure-Time Exercise Questionnaire
• Functional Assessment of Cancer Therapy (FACT)
• FACT-Anemia (FACT-An)
• FACT Head/Neck Symptom Index-22 (FHNSI-22)
• FACT-An Trial Outcome Index
• Center for Epidemiological Study Depression Scale (CESD)
• Patient-Generated Subjective Global Assessment (PG-SGA)
• Intervention survey
• Body composition, fitness, functional, flexibility tools

No significant differences were reported for lean body mass or percentage body fat during the 24 weeks. A main effect of time for lean body mass, body mass index, and percentage body fat was detected (lean body mass: F[2,74.5] = 54.141, p < 0.001; BMI: F[2,74.5] = 67.955, p < 0.001; percent body fat: F[2,74.5] = 29.679, p < 0.001). No between group statistical difference was detected for fitness outcomes, the six-minute walk test (6MWT), or the sit-to-stand test (SST), which may be because of the small sample size. No statistical differences were observed between the two groups’ quality of life during the 24-week period. A significant effect was observed on depression, but no associated difference was observed between study groups.

The intervention did not demonstrate an effect on patient outcomes.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable

This study did not show efficacy of an intervention involving exercise and supportive interventions. The findings are limited by study design aspects and sample size.

To observe the benefits of implementing an oral care protocol in the identification and treatment of stomatitis in patients with head and neck cancer receiving radiation and chemotherapy

Databases searched were CINAHL, the Cochrane Central Register of Controlled Trials, and Medline.

Search keywords were stomatitis, mucositis, mucous membrane, treatment protocols, clinical practice guidelines, radiation therapy, and chemotherapy.

A protocol was developed based on the literature. Nursing education was conducted regarding grading stomatitis based on World Health Organizaiton (WHO) guidelines and interventions for each grade. Patient education was developed regarding the key components of oral hygiene, along with creation of a stomatitis brochure. Chart audits were evaluated for a 20-day period pre- and post-intervention.

After protocol implementation, more cases of stomatitis were identified and stomatitis was identified at an earlier stage of severity.

Protocol use gives nurses the tools to identify high-risk patients and provide treatment.

Daily oral assessment and protocol use reduces the severity of stomatitis resulting in improved patient outcomes. This project could have been expanded and carried one step further by looking at both patients' and nurses' satisfaction and perceived effectiveness of the program.

To examine the effectiveness of an eight-week aquatic exercise program on cancer-related fatigue and physical and psychological outcomes in patients with breast cancer.

Patients were randomly assigned to exercise groups or usual care control groups. The intervention consisted of an eight-week program of water-based exercises, three times per week, in a heated deep swimming pool. Sessions lasted 60 minutes each and included a warm-up and cool-down. Exercise intensity was maintained according to recommendations for moderate exercise as stated by the American College of Sports Medicine and American Heart Association. Groups of 10 to 12 women participated in the exercise program. Data were collected at baseline, eight weeks, and six months.

• The sample was comprised of 61 participants.
• Mean participant age was 48 years.
• All participants were female.
• All participants had breast cancer. 
• The majority had undergone radiation and chemotherapy after surgery. 
• All had completed treatment other than ongoing hormone therapy.
• Of the participants, slightly more than 60% were married and 70% to 75% were postmenopausal.
• At baseline, all patients reported 32 to 38 minutes of activity per day. 
• All had completed treatment within the previous 18 months.

• Single site
• Outpatient
• Spain

Patients were undergoing the transition phase after active treatment.

This was a single-blind, randomized, controlled trial.

• Piper Fatigue Scale
• Profile of Mood States (POMS)
• Multiple sit-to-stand test
• Trunk curl static endurance test

• ANOVA showed a significant difference in all dimensions of fatigue and overall fatigue over time, between groups, with greater improvement in fatigue in the aquatic exercise group (p < 0.001). The overall effect size for total fatigue was d = 1.51 (95% confidence interval [CI] [1.13, 1.90]) at eight weeks. The overall effect size for severity of fatigue was d = 0.68 (95% CI [1.14, 1.22]). The intergroup effect size for total fatigue at six months was d = 0.87 (95% CI [0.48, 1.26]).
• Leg and abdominal muscle endurance for the sit-to-stand and abdominal curl tests was significantly higher in patients in the exercise group (p < 0.001).
• Groups showed a significant difference over time in favor of exercise (p = 0.029).
• The six-month follow-up revealed no effect of exercise on depression.

Deep-water exercise reduced fatigue, provided a short-term improvement in leg and abdominal muscle endurance, and resulted in some short-term reduction in depression. Effects on muscle endurance and depression declined after the eight-week program. Apparent effects on fatigue lasted six months.

• The study had a small sample size, with less than 100 participants.
• The study had a risk of bias due to lacking an appropriate attentional control condition.
• Unintended interventions or applicable interventions not described would influence results.
• The authors either did not know the components of patients' ongoing physical activities or did not describe them.
• The authors provided no information about adherence to the exercise program.
• The authors did not present an intention-to-treat analysis.
• The sample was very homogeneous, which limited the generalizability of the study.
• The authors did not address whether the exercise itself or involvement in group activity affected depression. 

The study adds to the large body of evidence showing the effectiveness of various types of exercise in the treatment of fatigue in patients with breast cancer. Nurses can recommend various types of exercise for their patients.

The intervention consisted of individual muscle relaxation training over three sessions plus instructions for home practice twice daily. Patients were either in the relaxation (n = 15) or usual care (n = 15) group. The outcome was sleep.

• The sample was comprised of 30 patients (11 men, 19 women).
• Mean age was 56 years (range 21–80).
• Patients had various cancers.

• Quiet office in the hospital, patient’s home, or patient’s hospital room
• Southeastern United States

Patients were undergoing the active treatment and long-term follow-up phases of care.

The study was a randomized, controlled trial.

Daily diary and questionnaire pertaining to sleep behavior the previous night, for a total of nine nights

Sleep-onset latency was reduced in the relaxation group compared with the usual care group; differences in sleep latency were maintained at the three-month follow-up. No differences were found in other sleep variables.

• Sleep was measured by self-reports.
• Training is needed in delivering muscle relaxation.

No cost issues existed.

To compare the effectiveness of two psychotropic medications, mirtazapine and imipramine, on distressing somatic symptoms (i.e., pain, nausea, vomiting, decreased appetite, and sleep disturbance) of cancer as well as symptoms of depression and anxiety.

Patients self-selected to receive psychotropic medication and supportive psychotherapy (intervention group) or supportive psychotherapy only. Those who elected to take medication were randomly enrolled to receive mirtazapine or imipramine. Mean dosage of mirtazapine ranged from 5 to 30 mg/day, depending on the visit. Mean dosage of imipramine ranged from 5 to 100 mg/day, depending on the visit. Each group was then assessed at three visits:  baseline and three and six weeks after therapy had begun.

• The sample was comprised of 53 patients with cancer (35%–38.5% male, 61.5%–65% female).
• Median age was 43 to 47.5 years (range 26–56).
• All cancer types were included; no information about cancer stage was provided. 
• In each group, median time since diagnosis ranged from 6.5 to 8 months.
• All patients had an additional psychiatric diagnosis. All had cancer; were undergoing chemotherapy; and had been diagnosed with major depressive disorder, adjustment disorder, and/or anxiety disorder.

• Single site
• Outpatient
• Large oncology research and training hospital in Turkey

Patients were undergoing the active treatment phase of care.

The study used a prospective, repeated measures design.

• Patient sociodemographic information    
• Pain, nausea, and vomiting (evaluated by single-symptom scale)
• Weight
• Appetite (evaluated by single item)
• Hamilton Rating Scale for Depression (HRSD) (three items to assess sleep disturbance)
• Hospital Anxiety and Depression Scale (HADS), Turkish version

• Among the three visits, no significant differences were observed with regard to the degree of pain, nausea, vomiting, or appetite in the mirtazapine, imipramine, and control groups, and nor did differences exist in terms of the scores relating to the degree of pain, nausea, vomiting, appetite, weight, or insomnia, among the mirtazapine, imipramine, and control groups.
• In the mirtazapine group, the initial, middle, and late insomnia scores improved between the first and second and first and third visits. In the control and imipramine groups, no significant change occurred in insomnia scores between visits.
• In the imipramine group, a significant difference was seen in weight at the three visits. Median weight decreased from the second to third visit.
• In the mirtazapine group, statistically significant differences were noted in the mean total, anxiety, and depression HADS scores at each visit. Especially notable were score changes between the first and second visit. In the imipramine and control groups, no differences were found in the total, anxiety, and depression HADS scores across visits. 

Mirtazapine is effective in resolving insomnia and in reducing the symptoms of anxiety and depression in patients with cancer who have depression, anxiety, or adjustment disorders.

• The study had a small, heterogeneous sample, with less than 100 patients.
• The study had a high drop-out rate; by six weeks, 10 of 20 patients had dropped out of the control group, 4 of 20 had dropped out of the mirtazapine group, and 4 of 13 had dropped out of the imipramine group.
• The study had no control group or random assignment and presented no information about confounding factors. 
• Patients were not controlled for use of concomitant medications to treat the somatic symptoms being evaluated.

Mirtazapine may be useful in treating anxiety, depression, and insomnia in patients undergoing chemotherapy for cancer who have clinically relevant anxiety or depression. More systematic research, such as placebo-controlled studies, is required.

To evaluate the efficacy of oral branched-chain amino acids versus placebo on anorexia and food intake in patients with cancer

A mixture of 4.8 g branched-chain amino acids was administered three times daily versus placebo powder three times daily for 60 minutes before each meal for seven consecutive days.

• The initial sample included 28 patients; attrition of 3 patients occurred secondary to early surgery not related to study (treatment arm = 13,  placebo arm = 12).
• Groups were equivalent in sex, age, and tumor origin.
• Patients were included in the study if they were newly diagnosed with cancer, undergoing surgical resection, experiencing anorexia, and not losing weight.
• None of the patients received radiotherapy or chemotherapy during the study or four weeks prior.

Multiple institutions in Italy that were not listed or further described

A double-blinded, placebo-controlled, randomized trial design was used.

• Nutritional status prior to and at end of study using biochemical indices
• Daily caloric intake measured by weighing food before and after each meal
• Presence of anorexia measured using questionnaire not described in the article
• Blood tests on days 0, 3, and 7 to measure levels of plasma amino acids and tryptophan

Nutritional status was within normal limits for both groups prior to and at the end of study. Daily caloric intake was significantly increased in the treatment arm. There was no change in the placebo group. Incidence of anorexia was significantly decreased in the treatment arm (100% prior to and 45% at the end of study). There was no significant change in the placebo arm (100% prior to and 84% at the end of study). Blood tests showed a significant increase in plasma amino acid levels and a decrease in free tryptophan levels in the treatment arm and no change in levels noted in the placebo arm.

• The study had a small sample size.
• Inclusion criteria was fairly narrow, including newly diagnosed, resectable patients who were not losing weight. Whether results can be applied to patients with cancer not meeting these criteria is questionable.
• The study had a short treatment time of seven days, leading to questions regarding long-term effects.
• The measurement tool used for anorexia was a questionnaire not described in this paper but rather referenced from a previous article.
• Anorexia was not defined.
• The study sites were not listed or described.

To update the information available on the effectiveness of laxatives and methylnaltrexone for constipation management in palliative care patients.

Databases searched were MEDLINE and the Cochrane Central Register of ControlLed Trials (Central).

Search keywords were laxatives, methylnaltrexone, and palliative care.

Studies were included in the review if

• They reported on adults receiving palliative care.
• Patients used laxatives or methylnaltrexone for constipation.

Studies were excluded if they reported on healthy volunteers, drug misuse–related constipation, or bowel obstruction.

A total of 186 references were retrieved. If citation screening did not identify whether a study was eligible, the full text was reviewed for acceptability. Two authors independently screened studies and discussed differences of opinion. Randomized controlled clinical trials were evaluated for inclusion.

• Seven studies comprising a total of 616 patients were included.
• Key characteristics were use of lactulose, senna, co-danthramer, misrakasneham,  and magnesium hydroxide with liquid paraffin.

• Patients were undergoing the end-of-life phase of care.
• The study has clinical applicability for palliative care.

• The best laxative for this patient population is unclear.
• Methylnaltrexone is effective in patients with opioid-induced constipation.

Well-designed clinical trials are needed to help identify which laxatives are most effective for palliative care patients with constipation.

Very few clinical trials effectively evaluated the use of laxatives in this patient population.

To determine whether more precise guidance can be given regarding use of osmotic laxatives, and to assess the evidence for their use in children with constipation.

Databases searched were PubMed, Embase, the Cochrane Library, and Google Scholar. Reference lists were also hand searched.

Search keywords were polyethylene glycols, lactulose, senna, bisacodyl, picosulphate, constipation, defecation, cathartics, infant, child, preschool, adolescent, and clinical trial.

Studies were included in the review if they

• Were a randomized clinical trial of osmotic laxative versus placebo or an active comparison
• Reported on patients aged younger than 18 years with a diagnosis of constipation of more than three months in absence of structural, endocrine, or metabolic disease
• Recorded a quantitative effect on constipation
• Were published in a peer-reviewed journal.

Initial searching provided 100 clinical trials and 71 review articles. A final group of seven trials was identified for consideration in this review.

The seven final studies encompassed data on 594 patients.

• A consensus appears to exist among studies that PEG is more effective than lactulose.
• One systematic review in 2006 found no evidence to support use of stimulant laxatives or bulk-forming agents among children.
• One study compared PEG 3550 with milk of magnesia. No difference existed between groups regarding bowel movements; however, more children refused treatment with milk of magnesia than with PEG (35% versus 5%, p < 0.001).

The review highlights the necessity of considering what treatment children will accept in managing symptoms.

This review was done in children with functional constipation, so findings may not be clearly applicable in children with constipation related to cancer treatment. PEG may be helpful and more effective than lactulose in the management of constipation in children with cancer, and may be more accepted than milk of magnesia.

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

No difference in effectiveness was demonstrated in lactulose compared with senna; senna plus lactulose compared with magnesium hydroxide plus liquid paraffin; misrakasneham compared with senna; and docusate plus senna compared with placebo plus senna.

The best laxatives for this patient population is unclear.

Very few clinical trials effectively evaluated the use of laxatives in this patient population.

More RCTs are needed to help evaluate the effectiveness and improve the quality of care of patients in palliative care.