To describe an evidence-based approach to using psychosocial interventions to manage anxiety and depression in adults with cancer

• Initially, authors included 14 systematic reviews and meta-analyses, including randomized and nonrandomized studies of patients with cancer. The final report included 13 studies. Literature was summarized in terms of randomized controlled trials (RCTs) that demonstrated efficacy, in managing anxiety or depression, based on intervention type and patient disease or treatment status.
• Authors presented intervention recommendations with significant (p < 0.05) effects relative to control.
• In addition, authors reviewed National Comprehensive Cancer Care Network (NCCN) Distress Management Guidelines and the clinical practice guidelines of Australia's National Breast Cancer Centre and the National Cancer Control Initiative's Practice Guidelines for the Psychosocial Care of Adults with Cancer (2003).
• The search strategy involved MEDLINE and PsychINFO resources. Authors did not list keywords.
• In addition, authors included existing systematic reviews and meta-analyses of effects of psychosocial interventions on anxiety and depression in adults with cancer and reviews of clinical practice guidelines relevant to distress and psychosocial care of adults with cancer. Exclusion criteria were not listed.

Authors provided examples of psychosocial interventions found to be effective. To be effective, the interventions

• Had to have been superior to a control condition in a published RCT
• Must have demonstrated good potential for dissemination
• Must have addressed common indications for preventing or managing anxiety or depression

Five interventions are illustrated:

• Psychoeducation for new patients with cancer, which resulted in significantly (p < 0.001) fewer symptoms of anxiety and depression as well as greater satisfaction (p < 0.01) with care provided than with usual care
• Patients randomized to problem-solving therapy, which demonstrated significantly (p < 0.05) less depression and maintained results through the one-year follow-up period
• Stress management techniques of paced abdominal breathing, progressive muscle relaxation with guided imagery, and the use of coping self-statements. These techniques yielded significantly less anxiety and depression (p < 0.05) than did usual care.
• Cognitive therapy evaluated against a wait-list control in breast cancer. Women who had clinically significant symptoms of depression demonstrated significantly (p < 0.01) less depression postintervention, with even further reduction occurring during the six-month follow-up period.
• Group cognitive-behavioral therapy for early-stage breast cancer survivors post-treatment, compared with no-intervention controls, indicated that the intervention group reported significantly (p < 0.05) less depression immediately postintervention and at two-year follow-up.

Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence recommends behavioral therapy, counseling or psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy. Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy in the post-treatment period.

In “summarizing the summaries,” limitations included differences in the scope, methods, and manner of summarizing findings and determining recommendations.

Weaknesses found in nearly all the studies included

• Gaps regarding the benefits of psychosocial interventions for diverse demographic, disease, and treatment characteristics. Men and ethnic and racial minorities were underrepresented, and most studies were based on several different types of cancer—usually, early-stage cancer.
• Inconsistency in the evaluation of interventions, number and timing of outcome assessments, and outcome measures used.
• Inadequate reporting of study methodology.
• Lack of research on patients who experience clinically significant anxiety or depression.

Future research should focus on men, minorities, patients with advanced disease, and those who have completed treatment. Studies must include patients who experience significant depression or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is needed as evidence to guide practice.

Databases searched were PsycINFO, MEDLINE, and CINAHL through November 2005.

Seventeen randomized, controlled trials of activity-based interventions were included in the meta-analysis. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. To be included, a trial must have included a controlled comparison arm with either a no treatment or placebo condition, must have been a study of an activity-based intervention in adults diagnosed with cancer, one of the study outcomes must have been fatigue or the related constructs of vitality or vigor, and the reported results must have included significant testing of differences between an intervention condition and a control condition.

In all 17 studies in which fatigue, vitality, or vigor was assessed as an outcome, more than three-quarters of the studies measured the construct of fatigue. Fatigue, vitality, or vigor was a primary outcome in slightly more than half of all the studies of activity-based interventions, and it was a secondary outcome in the remainder. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. There were numerous differences across these studies in the type of exercise (e.g., aerobic or resistance), mode (e.g., walking or cycle ergometer), and intensity of exercise.

Sixteen of the 17 studies used no intervention control groups or wait-list control groups, and one study used a placebo control condition that involved stretching exercises. Sixty-one percent of the studies provided a home-based exercise intervention and 39% provided supervised exercise programs. No study specified the levels of fatigue, vigor, or vitality used as the eligibility criterion.

• Ten of the 17 trials were in patients with breast cancer only.
• Eleven studies included patients undergoing or about to start chemotherapy and/or radiotherapy, and five included only patients who had completed treatment.
• With regard to disease severity, 10 studies included only patients with nonmetastatic disease, and the remaining studies either did not specify metastatic status or were not restricted in terms of metastatic status.
• The total sample size for each activity-based intervention study ranged from 14 to 155 patients (median = 50 patients).

The effect size for activity-based interventions was not statistically significant (d_w = 0.05; 95% confidence interval [CI] [-0.08, -0.19]), and there were no differences in effect sizes as a function of cancer type (breast cancer:  d_w = 0.12; 95% CI [-0.15, -0.30]) or for all other types (d_w = 0.06; 95% CI [-0.11, -0.24]) or intervention modality (home-based:  d_w = 0.04; 95% CI [-0.13, -0.22]; supervised:  d_w = 0.16; 95% CI [-0.09, -0.41]).

• As with all meta-analyses of exercise that pool results across studies, there was variability in the type, mode, and intensity of exercise, as well as variation in the duration of the intervention and whether the intervention was supervised or home-based.
• Few studies provided an analysis of adherence effects in the intervention group, and no study reviewed by the authors required study participants to have a clinically significant level of fatigue. As a result, the possibility exists that many participants were experiencing little or no fatigue at the time of study entry, thus limiting the ability of these study designs to detect intervention effects.

The current results conflict with the results and conclusions made by other authors who conducted narrative systematic reviews of single studies, with meta-analyses that included both randomized and nonrandomized trials, and with the results of another meta-analysis published more recently. Close comparison of the studies reviewed by the current authors with those reviewed by Cramp and Daniel suggest that the conclusions were different in part because different randomized, controlled trials were examined. Six randomized, controlled trials of activity-based interventions with favorable effects on the outcome of cancer-related fatigue were published after the current authors completed their electronic database searches. In addition, the search strategies used by the current authors excluded two randomized, controlled trials that reported activity interventions (Galantino 2003; Dimeo 2004) that met the criteria for inclusion in their meta-analysis. Moreover, a meta-analysis published in April 2008 by the Cochrane Collaboration that included these more recently published trials together with the two trials that were inadvertently excluded by the current authors concluded that there was a small but statistically significant effect for exercise (standardized mean difference = -0.23; 95% CI [-0.33, -0.13]).

Evaluate the effects of stress management training and exercise, alone or in combination, on well-being, depression, and anxiety among patients during chemotherapy treatment

Patients were stratified by gender, physical activity level, treatment schedule, and whether they also were receiving radiation therapy. They then were randomly assigned to one of four groups: usual care only (UCO), exercise (EX), stress management training (SM), or exercise plus stress management training (SMEX). The SM group met with an interventionist before the first chemotherapy infusion and was provided with a 15-minute video, a booklet, and an audio recording that provided information and instructions for paced breathing, progressive muscle relaxation with guided imagery, and coping statements to manage stress. Patients were instructed on how to learn and use the techniques during chemotherapy. The EX group met with the interventionis before the first infusion and was given a video and booklet providing instructions on use of regular exercise during treatment, with an emphasis on walking. These patients also were provided with pedometers. Patients were advised to exercise for 20–30 minutes three to five times per week and were provided with heart rate targets and shown how to use pulse rate to monitor exercise intensity. The SMEX group was provided with exercise and stress management resources. All patients had the same usual care access to the full range of psychological services provided to all patients and were given information about chemotherapy with written materials. Assessments were done at baseline (T1), six weeks (T2), and 12 weeks (T3). Exercise was self-directed and home-based.

• N = 286  
• MEAN AGE: 57.5 years
• MALES: 34%, FEMALES: 66%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types. The majority were not receiving concomitant radiation therapy.
• OTHER KEY SAMPLE CHARACTERISTICS: More than one-third were college graduates and were married or partnered. All were adults.

• SITE: Single site   
• SETTING TYPE: Home   
• LOCATION: Florida

PHASE OF CARE: Active anti-tumor treatment

• Randomized, controlled trial
• Four groups

• MOS–SF36
• Center for Epidemiological Studies Depression Scale (CESD)
• Beck Anxiety Inventory (BAI)
• Godin Leisure-Time Exercise Questionnaire

The SMEX group had a significant reduction in depressive symptoms compared to the UCO group (p = .048). All groups except for the UCO group showed a decrease in depressive symptoms over time. The effect size was small at its maximum (d = 0.25). BAI scores showed a positive effect in the SMEX group compared to the UCO group (p = .049). In the SMEX group, this decline occurred mainly between baseline and the first follow-up at six weeks, and then anxiety scores increased. The maximum effect size was small (d = .22). No significant differences were seen between the UCO and EX or SM groups in anxiety or depression over time. Exercise and stress management activities increased only in the SMEX group.

The combination of exercise and stress management training reduced anxiety and depressive symptoms during chemotherapy treatment. Exercise alone and stress management training alone did no show positive results. The size of the effect of SMEX was small.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• By the first follow-up, about one-third of the patients withdrew. By the investigator's calculations, the study was underpowered.

Findings suggest that the combination of stress management training, using approaches such as progressive muscle relaxation and guided imagery with home-based exercise delivered via video and written guidelines, had a small effect on improving anxiety and depressive symptoms among patients receiving chemotherapy.  This combination was more effective than relaxation training and exercise alone. This suggests that nurses can educate patients to use both of these approaches to manage these symptoms. Effect sizes seen here were small, and the intervention consisted of a single instructional face-to-face meeting and then patient self-directed activity using resources provided. More personal time and follow-up support and encouragement during treatment sessions may increase the magnitude of the effects. Provision of videos and written materials as used here can provide a practical approach to patient education in these areas.

STUDY PURPOSE: To describe an evidence-based approach to the use of psychosocial interventions to manage anxiety and depression in adults with cancer

TYPE OF STUDY: Combined systematic review and meta-analysis

• FINAL NUMBER OF STUDIES INCLUDED = 13
• TOTAL PATIENTS INCLUDED IN REVIEW = Not stated
• SAMPLE RANGE ACROSS STUDIES: Not described
• KEY SAMPLE CHARACTERISTICS: Not described

PHASE OF CARE: Active treatment

APPLICATIONS: Late effects and survivorship

Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence yielded recommendations for behavioral therapy, counseling/psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy.  

Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy in the post-treatment period.

1. Psychoeducation for new patients with cancer reported significantly less anxiety and depressive symptoms (p < 0.001) as well as greater satisfaction with their care than usual care (p < 0.01).
2. Patients randomized to problem-solving therapy demonstrated significantly less depression (p < 0.05), and results were maintained through a one-year follow-up period.
3. Stress-management techniques of paced abdominal breathing, progressive muscle relaxation with guided imagery, and the use of coping self-statements were briefly taught and provided to patients via print and audiovisual materials prior to beginning chemotherapy. Significantly less anxiety and depression (p < 0.05) was found versus usual care.
4. Cognitive therapy evaluated against a wait-list control in women with breast cancer who had clinically significant depressive symptoms demonstrated significantly less depression postintervention (p < 0.01), with even a further reduction occurring during the six-month follow-up period.
5. Group cognitive-behavioral therapy was offered to early-stage breast cancer survivors post treatment; the efficacy of this intervention in an randomized controlled trial compared with no-intervention controls indicated that the intervention group reported significantly (p < 0.05) less depression immediately postintervention and at two-year follow-up.

• Gaps regarding benefits of psychosocial interventions for diverse demographic, disease, and treatment characteristics. Men and ethnic and racial minorities were underrepresented, and most studies were based on several different types of cancer, usually early stage. 
• Inconsistency in the evaluation of interventions, the number and timing of outcome assessments, and outcome measures used
• Inadequate reporting of study methodology 
• Lack of research on patients experiencing clinically significant anxiety or depression (most patients studied were experiencing low levels when recruited)

Future research is needed, particularly focusing on men, minorities, patients with advanced disease, and patients who have completed treatment. Studies must include patients experiencing significant depression and/or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is important, but current data specify only “vulnerable times” rather than evidence to guide practice.

This was a preliminary trial evaluating effectiveness of two types of homeopathy for treatment of menopausal symptoms in breast cancer survivors.

At the initial visit, a homeopathic practitioner conducted a homeopathic evaluation of each participant and prescribed an individualized homeopathic medication that best matched the symptom profile for that participant. A homeopathic pharmacist randomized the participants tothree treatment groups:

1. A placebo combination medicine and a verum single remedy
2. A verum combination medicine and a placebo single remedy
3. Two placebo medications

All study medications were donated by the Standard Homeopathic Company. The treatments were identical in taste, appearance, and odor and were dispensed in identical containers. The combination medicine was Hyland’s Menopause, which is sold over-the-counter in the United States. It contained three homeopathic medicines: Amyl nitrate, Sanguinaria canadensis, and Lachesis.

Participants were mailed a one-week daily hot flush diary to complete during the week prior to call.

Eighty-three (83) participants completed the initial homeopathic visit and were randomized into the three treatment groups. Of this total, 28 patients (33.7%) withdrew, including 11 who reported no relief from hot flashes, 7 who had a cancer recurrence or withdrew because of other illness, 5 who said the study was inconvenient, and 4 who were lost to follow up. Sixty-six (66) participants completed at least six months of the study (80.5%).

• Inclusion criteria:
  • Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment.
  • Tamoxifen use was allowed.
  • Participants had a history of hot flashes for at least one month, with an average of at least three hot flashes per day in the week prior to beginning treatment.
• Exclusion criteria:
  • Other medications for the treatment of hot flashes, including specific vitamin regimens, herbs, estrogen or progestational agents, antidepressants, or sleep medications were not permitted.
  • Concurrent chronic health problems such as rheumatoid arthritis, asthma, heart disease, and inflammatory bowel disease and corticosteroid use.
  • Those expected to receive additional chemotherapy or radiation treatment within the next year were not allowed to participate.
  • Women who were pregnant or planned to become pregnant in the next year were also excluded.

Participants stratified by age (younger or older than 50 years), breast cancer staging, and use of tamoxifen.

The study was a randomized, double-blinded, placebo-controlled trial. Participants received controlled an individualized homeopathic single remedy, homeopathic combination medicine, or a placebo.

Homeopathic providers saw or called participants every two months for one year.

No significant difference was reported for the primary outcome measure, the hot flash severity score, or in the total hot flashes among the three groups in the univariate model adjusted for baseline, time, and tamoxifen use over the period of 1 year. The single remedy group had a lower severity score and fewer hot flashes as a whole, which was most marked during the first three months of the study, with a positive trend (p = 0.1) at three months compared to placebo. However, in the combination homeopathy group not receiving tamoxifen, there was a statistically significant increase in the hot flash severity score compared to placebo (p= 0.01) and a highly significant difference when compared to single homeopathic remedy (p= 0.001). Similarly, there was a highly significant increase in the total number of hot flashes in the combination group compared to placebo (p = 0.006) and compared to single remedy (p=0.002) in the group not receiving tamoxifen. There was also a statistically significant increase in headaches in the group receiving the homeopathic combination at 6 months (p = 0.04) and 12 months (p = 0.03). In the multivariate analysis, which included baseline values, time, age, last month in the study, and treatment group, the same statistically significant relationships between treatment group and tamoxifen/no tamoxifen were found for both severity score and total number of hot flashes.

The small sample size precludes definitive answers. Difficulty in retaining participants for one year was a major problem. Use of three arms made treatment decisions difficult, although the average number of remedy changes found over the one-year study period is not unusual in homeopathic practice. Use of the homeopathic combination medicine in an ongoing daily regimen, rather than as it is used in current over-the-counter treatment, was a major flaw in this study.

To assess the efficacy and adverse effects of a ketamine burst protocol for pain relief in patients with refractory pain

Patients received IV ketamine at three dose levels (100, 300, and 500 mg per 24 hours) over 3–5 days in inpatient palliative care settings. All other medications remained, and benzodiazepines or haloperidol could be used to minimize adverse psychotomimetic events. Maintenance doses of 24 opioids and breakthrough pain opioid dosing could be reduced as appropriate for pain control. Data were collected on pain scores and total opioid intake during ketamine infusions and for 48 hours post infusion.

• The sample consisted of 44 patients.
• The median age was 61 years, with a range of 35–82 years.
• The sample was 52% female and 48% male.
• The majority of primary malignancies were lung, breast, colorectal, head and neck, mesothelioma, and multiple myeloma.
• Patients had various types of pain, including neuropathic (64%), pain from bony metastases (25%), and somatic pain (32%).
• All patients had pain scores of 4 or more at baseline, using a verbal rating scale.
• Pretreatment morphine-dose equivalents for opioid intake ranged from 3–1,050 mg per 24 hours.

This was a multisite study conducted in an inpatient setting in Australia.

This was an open-label, prospective study.

Patients were assessed based on the European Cooperative Oncology Group (ECOG) performance status, National Cancer Institute (NCI) Common Toxicity Criteria, and a pain verbal rating scale (which was not described).

• In all, 77% of patients required 300 mg or more of ketamine and 41% required 500 mg per 24 hours. Half of the participants were classified as responders to the ketamine.
• The longest documented response was 3 months in one patient; 11 patients continued with defined response for 2 weeks.
• More than half (61%) of patients experienced low-grade adverse effects. All grade 3 and 4 side effects occurred in patients who needed at least  300 mg per 24 hours of ketamine.
• Injection site toxicity was the most frequent grade 3 toxicity, and the most frequent grade 4 toxicity was hallucinations. No responding patient required withdrawal because of neurological adverse events.

Findings suggest that use of a ketamine burst infusion may be helpful for pain relief in some patients with cancer-related refractory pain.

• The sample size was small, with fewer than 100 patients.
• No comparison or control group was included.
• Opioid intake and episodes of breakthrough pain were not reported, although these were stated as outcomes of interest in the study.
• Refractory pain was defined as at least 4 on the rating scale, but duration of pain was not described in the population.
• Use of adjuvant pain medications was not described; therefore, subgroup analyis could not be done based on other medication intake.
• Statistical analysis of findings was not included.

In patients with pain that is not effectively controlled by other means, approaches such as ketamine infusions may have some benefit. More research in ketamine use is warranted. Although some patients responded and had a duration of effect as long as three months, 50% of patients did not respond as defined. Use of this approach requires hospitalization with continuous infusion and monitoring.

To examine research about the effectiveness of therapeutic touch in decreasing the pain and anxiety of patients with cancer

• Databases searched were PubMed, CINAHL, and the Cochrane Library.
• Search keywords were healing touch, therapeutic touch, cancer, and pain and anxiety.
• Studies were included if they
  • Researched the use of therapeutic touch in the context of any type of cancer.
  • Used therapeutic touch as the independent variable and pain or anxiety as the dependent variable.
• Exclusion criteria were not cited.
• Although the initial search strategy did not include the search keywords healing touch or Reike, these terms were included later.

• The study does not cite the number of studies retrieved or how authors assessed the studies for inclusion.
• Studies were organized, according to the quality of the evidence, by using the seven-level rating system that Melnyk proposed.

• Authors included 12 studies in the analysis.
• Sample size across all 12 studies was 6,066 patients. The range of sample sizes was 9–5,457.

• Authors identified only one study as a level 1 study. This study, a systematic review of 18 studies, concluded that, though evidence showed therapeutic touch to be a promising intervention, the evidence to support recommending therapeutic touch was inadequate.
• Three studies reported positive results, demonstrating that therapeutic touch was associated with significant improvement in physical and psychological health.
• The analysis yielded no results regarding the direct effect of therapeutic touch on pain or anxiety. Studies in this regard, three cohort or case control studies, were of low quality. Authors assessed them as level 3 nonrandomized controlled trials. One of these trials reported significant reduction (p = 0.03) of measured anxiety during the perioperative period.

The authors report that research relating to therapeutic touch indicates that the therapy helps to reduce pain and anxiety; however, the evidence that the research provides is very weak. Few studies showed statistically significant results, and several studies did not directly measure either variable. The rating scale used does not take sample size into account. As a result, a study rated level II included only 20 patients. Even with this rating scale, most studies analyzed were of low quality. Although the purpose of this study was to summarize the research, the authors incorporated opinion and review articles that were in support of therapeutic touch.

The evidence to support the efficacy of therapeutic touch, as a means of reducing the pain and anxiety of patients with cancer, is weak because the research about this topic is of low quality. Many investigators believe that therapeutic touch and related interventions are promising for patients with cancer and that the interventions pose little risk. Delivering these interventions requires training, however. Some authors have noted that, compared to inexperienced practitioners, experienced practitioners achieve more significant results. Therapeutic touch is something to consider as an adjunctive treatment for the pain and anxiety of patients with cancer. However, therapeutic touch must be administered by a trained and experienced practitioner. Well-designed and appropriately powered research of the efficacy of therapeutic touch is warranted.

STUDY PURPOSE: To examine the current amount and quality of evidence for the standard treatment of lower limb lymphedema (LLL) after treatment for gynecologic cancers

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 3
• TOTAL PATIENTS INCLUDED IN REVIEW = 55
• SAMPLE RANGE ACROSS STUDIES: 54–158 participants
• KEY SAMPLE CHARACTERISTICS: The review addressed women who had prior radiation, chemotherapy, surgery, or lymph node removal for the diagnosis of a gynecologic cancer and received standard care: complex decongestive therapy (CDT)

PHASE OF CARE: Late effects and survivorship

The evidence was weak (IIIC) but did show an overall decreased volume of limb(s) after CDT.

Despite the accepted and common recommendation to use CDT for LLL treatment, few studies support this in an evidence-based environment.

• Limited number of studies included
• Mostly low quality/high risk of bias studies
• Poor or awkward wording at times and structuring of the writeup, which were perhaps because of a typo/discrepancy between the titles initially identified as numbering 121 (in first paragraph of the Results section) and then 120 listed in Figure 1 flowchart
• The number of final studies included was listed as “5,” then changed to “3” without a clear explanation in the Results writeup, making it difficult to review.
• The graded evidence was weak (IIIC per results), and no randomized trials existed.
• One of the studies seemed to focus more on quality of life, and the clinical outcomes were secondary (Kim and Park, 2008).

The value of this review is that it highlights the limited evidence and research attempted, to date, for standard LLL treatment. More research is needed in this area, particularly randomized, clinical trials. Hopefully, this encourages nurses to initiate research to better support evidence-based practice and interventions for women with LLL.

To investigate the effectiveness of a dietary supplement amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in patients with breast cancer

A dietary supplement containing branched chain amino acids coenzyme Q10 and L-carnitine was given orally once daily for 21 days at a dose of 125 g. Patients in the control group received usual care. Study assessments were conducted on day 1 and day 22, and fatigue was measured on days 8 and 15.

• N = 57  
• MEDIAN AGE = 50 years
• AGE RANGE = 22–70 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer; 89% had recurrence, and 86% had metastases. All were receiving chemotherapy, with varied regimens.

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

• PHASE OF CARE: Active antitumor treatment

• Open-label, multicenter, randomized, controlled trial

• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30)
• EORTC QLQ-BR-23

Fatigue initially increased from baseline to day 8 and then declined in both groups. The mean change in worst level of fatigue was greater with the intervention (p = 0.005). The mean reduction in current level of fatigue was greater with the intervention (p = 0.0009). No differences existed between groups in average feeling of fatigue or anxiety and depression scores.

The dietary supplement tested here may have some benefit in controlling fatigue among patients with breast cancer during chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• The study was underpowered.
• No placebo control
• Baseline fatigue levels were not reported, so whether baseline fatigue was clinically relevant is unknown.

These findings suggest that a dietary supplement of branched chain amino acids coenzyme Q10 and L-carnitine may be helpful for the management of fatigue. Further research is needed to confirm this potential.

To evaluate whether all patients undergoing highly emetogenic chemotherapy (HEC) need an NK₁ and to evaluate the effects of aprepitant on patients who experience chemotherapy-induced nausea and vomiting (CINV) in the first course of therapy

Patients received standard antiemetics consisting of IV granisetron on day 1 and dexamethasone on days 1–3 when given highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Patients who needed aprepitant experienced CINV and received aprepitant prophylactically for the subsequent courses of chemotherapy. Other agents for rescue antiemesis were allowed. Pharmacists visited patients on days 1–6 to assist them with completing diaries to record symptoms.

• N = 77
• MEAN AGE = 67 years
• AGE RANGE = 38–85 years
• MALES: 83.1%, FEMALES: 16.9%
• KEY DISEASE CHARACTERISTICS: Of the patients, 93.5% had lung cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 36.4% were receiving HEC and the rest were receiving MEC.

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

• PHASE OF CARE: Active antitumor treatment

• Retrospective, descriptive

• Eleven-point numeric rating scale for nausea
• Functional Living Index-Emesis (FLIE)

Eighteen patients (23%) needed aprepitant after the first course of chemotherapy. Those receiving HEC who needed aprepitant experienced a significant improvement in the prevention of CINV (p = 0.018) and had less need for rescue medications (p = 0.001). Those receiving MEC also experienced an improvement in CINV after the use of aprepitant, although the difference was not statistically significant. Most improvement was seen in the delayed phase. Though vomiting was reduced, no significant improvement in nausea was observed. About 50% of patients required rescue antiemetics with the first course of chemotherapy.

Not all patients receiving HEC or MEC need an NK₁ to prevent CINV. Aprepitant was effective in preventing vomiting in patients who had CINV during the first course of chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• No information regarding rescue medications used is provided.

The findings suggest that all patients may not need NK₁s for complete control of CINV; however, no evidence predicts which patients will or will not experience CINV without an NK₁. Current guidelines recommend triplet antiemetics for HEC. Further work to identify the factors that would predict the patients who need NK₁s would be helpful to potentially provide control of CINV without the high cost of NK₁s.