To evaluate the psychological effects of presurgical stress management training

Subjects were randomized to the intervention or control group by week in the hospital. The intervention consisted of four sessions of meditative exercises, relaxation, guided imagery, and counseling to promote active coping and positive attitude. Sessions were completed on days 5 and 1 before surgery and days 2 and 30 postsurgery. Patients were given a CD with the same instructions to use at home. Assessments were done on days 6 and 1 before surgery and days 2, 5, 30, and 90 postsurgery. The control group received usual care.

• N = 70
• MEAN AGE = 52 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; all stages undergoing surgery; most had lumpectomy

• SITE: Single-site
• SETTING TYPE: Multiple settings
• LOCATION: Netherlands

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)
• Profile of Mood States (POMS) scale for fatigue and depression
• Subjective sleep quality scale
• Numeric Pain Rating Scale (NRS)

Anxiety decreased after surgery in both groups. Depression decreased in the intervention group after surgery and in the control group at three months postsurgery. Depression was significantly lower in the intervention group on day 5 after surgery (d = 0.47). Fatigue increased in the control group and was significantly higher than baseline at three months postoperatively. In the intervention group, fatigue decreased and was significantly below baseline at days 2 and 5 postoperatively. Sleep problems and pain did not change in either group. Across all study timepoints, differences between groups were inconsistent. Sometimes, symptoms were higher in the intervention group, and other times, they were lower in the intervention group. An analysis was done for changes from baseline for each group rather than between groups. There were only differences in the degree of change from baseline to postoperative days 2 and 5.

The effects of the intervention were inconsistent over time and appeared to be modest and short-lasting.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Though small, the power analysis showed that the sample was sufficient to detect moderate effects. Baseline depression and fatigue levels were much higher in the intervention group, suggesting floor effects in the control patients. Six repeated measures could produce testing effects. There was no information about how often patients used the CDs at home. No information regarding other known intervention variables, including any adjuvant treatment during the study period, was provided.

The findings here were somewhat confusing and inconsistent over time; however, there were some potential short-term benefits for fatigue and depression. The combination of relaxation therapies and counseling is a low-risk intervention that may be helpful for some patients.

To evaluate the impact of quinolone prophylaxis during neutropenia on outcomes including resistance rates and hospital admissions

Researchers compared data from hospitalizations during two time periods, representing an intervention group and a control group. The intervention group included patients who received quinolone prophylaxis from 2006–2008. Prophylaxis consisted of 500 mg oral ciprofloxacin twice a day or 200 mg IV twice a day if oral medication was not tolerated. The control group included patients who received no antibiotic prophylaxis during 2005. In the event of a fever, patients in both groups began IV cefepime. If patients had a history of a cefepime-resistant gram-negative infection, they were treated with a carbapenem instead. Analysis of demographics and clinical outcomes, including occurrence of fever, duration of empirical antibiotic therapy, duration of hospitalization, and quinolone resistance, were conducted using SPSS software. Chi-square tests and Mann-Whitney tests were used for categorical and continuous variables, respectively. To evaluate patterns of resistance, data from patients outside the intervention cohort, but also hospitalized from 2006–2008, also were analyzed for resistance.

• N = 220 patients (141 in ciprofloxacin prophylaxis group, 79 in control group). Some patients were included more than once if more than 30 days passed between episodes of neutropenia. Thus, in 220 patients, 329 episodes of neutropenia occurred (219 in ciprofloxacin prophylaxis group, 110 in control group).
• AGE: Ciprofloxacin: mean age = 40 years (age range: 14–82 years); Control: mean age = 41 years (age range: 12–66 years)
• MALES: 60% in ciprofloxacin, 66% in control; FEMALES: 40% in ciprofloxacin, 34% in control
• KEY DISEASE CHARACTERISTICS: All patients were receiving intensive chemotherapy for a hematologic malignancy or undergoing hematopoietic cell transplantation (HCT). Diseases for ciprofloxacin and control groups, respectively, are primarily blood cancers, including leukemia (44%, 42%), lymphoma (26%, 21%), and multiple myeloma (26%, 28%). Other diseases represented include germ cell tumors and aplastic anemia.
• OTHER KEY SAMPLE CHARACTERISTICS: More than half of the episodes in each group included patients undergoing autologous or allogeneic HCT. Nearly two-thirds of the episodes in each group included patients with a central venous catheter.

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

• PHASE OF CARE: Active antitumor treatment

• A retrospective, observational case-control study

For their methods, the researchers defined neutropenia as an absolute neutrophil count (ANC) less than 500/mm³. They defined bone marrow recovery as at least two consecutive days with ANC greater than 500/mm³. All blood cultures were processed using a BacT/ALERT^® system. Susceptibility tests were completed using the VITEK^® automated system. Other laboratory tests on stored bacterial cultures were used to evaluate susceptibility. These included, but were not limited to, disk diffusion, minimal inhibitory concentration, and polymerase chain reaction. Statistical tests, including Chi-square and Mann-Whitney, were completed using SPSS software.

Groups were similar in age and gender. The intervention group was statistically different from the control group in that they experienced slightly shorter periods of neutropenia (9 versus 11 days, p = 0.02), hospitalization (22 versus 24 days, p = 0.002), and antibiotic therapy (8 versus 11 days, p < 0.001); fewer febrile episodes (73 versus 93%, p < 0.001), decreased incidence of any grade mucositis (52% versus 70%, p = 0.003), and bacteremia (22% versus 33%, p = 0.04); and increased use of carbapenem (36% versus 14%, p < 0.001). The intervention group had a higher rate of quinolone-resistant bacteremia (6.77 versus 3.02 per 1,000 patients-day, p = 0.03). Quinolone-resistant enterobacteria was noted in the intervention group and patients outside the intervention cohort but hospitalized during the same time. The rate of extended spectrum beta-lactamase (ESBL)-producing enterobacteria was not significantly increased in the intervention group (0.38 in the control group versus 1.27 in the ciprofloxacin group, p = 0.26).

This study identifies benefits of quinolone prophylaxis in high-risk patients (i.e., patients with hematologic malignancies undergoing chemotherapy with an expected duration of neutropenia longer than seven days, or patients undergoing HCT), including decreased incidence of fever, bacteremia, duration of neutropenia, and length of hospitalization. Risks include an increased incidence of quinolone resistance and bacteremia because of ESBL-producing enterobacteria for the patient and hospital unit.

• Risk of bias (no random assignment)
• Other limitations/explanation: The two cohorts being compared were historical and in different time periods. The authors report no changes in hospital policy or procedures between the two time points; other differences not measured may include different staff or training. Finally, as the data were historical, not all patients included in the cohorts had bacterial samples recovered and saved for further analysis.

Quinolone prophylaxis can reduce the incidence of fever, bacteremia, duration of neutropenia, hospitalization, and duration of antibiotic therapy for select high-risk patients. Nurses should understand these benefits and the risk of quinolone resistance for individual patients in the surrounding hospital unit.

To compare the impact of a mindfulness-based cancer recovery (MBCR) intervention versus cognitive behavioral therapy for insomnia (CBT-I) on mindfulness and dysfunctional sleep beliefs, to examine associations of insomnia severity and changes in mindfulness and dysfunctional sleep beliefs, and to compare changes in insomnia severity between treatment groups

MBCR was used on-site at weekly 90-minute group classes with one six-hour silent retreat between weeks 6 and 7 as an opportunity for extended practice. The program consists of several types of mindfulness practices and didactic instruction on application of mindfulness attitudes. The facilitator was a nurse with more than 10 years of experience delivering MBCR. The CBT-I program consisted of eight weekly 90-minutes sessions, including stimulus control, sleep restriction, relaxation, cognitive strategies aimed at dysfunctional sleep beliefs, and sleep hygiene. The facilitator for the CBT-I program was a doctoral level trainee in a nationally accredited clinical psychology program and was supervised by a PhD-level Clinical Health Psychologist.

• N = 72  
• MEAN AGE: No sample mean
• AGE RANGE: 36–88 years
• MALES: 27.8%, FEMALES: 72.2%
• KEY DISEASE CHARACTERISTICS: The study included patients with breast, prostate, blood/lymph, female genitourinary, lung, head/neck, or colorectal cancers; and survivors with non-metastatic disease who had completed treatment at least one month prior to study participation.
• OTHER KEY SAMPLE CHARACTERISTICS: 64% were married and 58% were employed.

• SITE: Single site
• SETTING TYPE: Outpatient  
• LOCATION: University of Calgary/Alberta Health Services

• PHASE OF CARE: Late effects and survivorship

• Secondary analysis of randomized, controlled trail data
• Parent study compared MBCR with CBT-I for treatment of insomnia in patients with cancer

• Five Facet Mindfulness Questionnaire (FFMQ)
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
• Insomnia Severity Index (ISI)

Mindfulness outcomes not reported. There were significant group, time, and group X time effects on overall and subscale scores for the DBAS with large effect sizes. The CBT-I group had more improvements than the MBCR group. Baseline to post-program improvements were noted that persisted at three-month follow-up. Associations between DBAS subscale and total scores and insomnia severity were not reported. Aspects of mindfulness were negatively correlated with a number of DBAS subscales and total score. Insomnia severity was negatively correlated with mindfulness non-judging. Insomnia severity (severe, moderate, mild, none) was not significantly different at baseline, post-program, and follow-up between MBCR and CBT-I groups.

CBT-I has a greater impact on DBAS measures than MBCR, but both have large effect sizes on DBAS. Aspects of mindfulness account for some variability in DBAS scores. Both MBCR and CBT-I have a positive impact on insomnia severity over time.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Findings not generalizable
• A number of risks for bias are unknown. The parent study is not referenced; therefore, the number of people who refused to participate or the attrition rate or allocation sequence and concealment is unknown. Analysis was per protocol. Results should be taken with caution.

Both CBT-I and MBCR may improve insomnia in survivors. CBT-I has a greater impact in decreasing dysfunctional beliefs about sleep.

To examine whether mindfulness-based stress reduction (MBSR) is noninferior to cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia in patients with cancer

• N = 111  
• MEAN AGE = 58.89 years (SD = 11.08 years)
• AGE RANGE = 35–88 years
• MALES: 28%, FEMALES: 72%
• KEY DISEASE CHARACTERISTICS: Patients with mixed nonmetastatic cancer who had insomnia and completed primary treatment at least one month prior; 48% had breast cancer, and 12% had prostate cancer; mean cancer duration was 3.9 years (SD = 4.03 years); treatments included surgery, chemotherapy, radiation, and hormonal therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Mean education was 15.14 years (SD = 3.53 years); 90% white/European

• SITE: Single site    
• SETTING TYPE: Tertiary cancer center    
• LOCATION: Calgary, Canada

• PHASE OF CARE: Long-term survivorship (at least one month since active, primary treatment)

• Randomized, partially blinded, noninferiority trail

• Insomnia Severity Index (ISI)
• Daily sleep diaries
• Actigraph GT1M
• Calgary Symptoms of Stress Inventory
• Profile of Mood States (POMS)
• Dysfunctional Beliefs and Attitude About Sleep (DBAS)

Of 327 patients screened, 111 were assigned randomly (CBT-I, n = 47; MBSR, n = 64). MBSR was inferior to CBT-I for improving insomnia severity immediately after the program (p = .35), but MBSR demonstrated noninferiority at follow-up (p = .02). Sleep diary-measured sleep latency (minutes to fall asleep) was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in wake after sleep onset (in minutes) were observed for both groups. Total sleep time increased by 0.60 hours for CBT-I and 0.75 hours for MBSR. CBT-I improved sleep quality (p = .001) and dysfunctional sleep beliefs (p = .001), whereas both groups experienced reduced stress (p = .001) and mood disturbance (p = .001).

Although MBSR produced a clinically significant change in sleep and psychological outcomes, CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia.

• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: The most notable limitation is the differential attrition observed between groups. Although the reasons are unknown, participant preference may have contributed to the significant attrition in the MBSR group compared with CBT-I because how learning meditation and yoga could contribute to sleep improvements may be less obvious to participants not already inclined to choose MBSR. The findings are not generalizable to a more racially diverse population (90% white/European). The absence of a no-treatment control group prevents an exploration of alternate explanations for change over time. The additional six hours of contact time received by participants in the MBSR group raises the possibility of even greater relative improvement for the CBT-I group if it had been matched for time. Treatment integrity was not formally assessed; however, the research was designed to minimize risk of treatment contamination, and measures were taken throughout the study to promote fidelity.

Noninferiority of MBSR only was demonstrated at the five-month follow-up, suggesting that although MBSR may produce clinically significant improvements with time, the treatment effects of CBT-I are rapid and durable. Thus, CBT-I remains the treatment of choice for patients with cancer who have insomnia.

STUDY PURPOSE: To review the efficacy of cognitive behavioral therapy (CBT) on sleep and psychological outcomes in patients with cancer and cancer survivors

• FINAL NUMBER STUDIES INCLUDED = 12
• SAMPLE RANGE ACROSS STUDIES = 10–260
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,153
• KEY SAMPLE CHARACTERISTICS: Most studies in breast cancer, but a few in mixed diseases

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Four of four uncontrolled trials showed a positive significant effect of CBT on sleep problems. Of eight RCTs, five showed a positive significant effect and three showed no difference between groups. One of these compared CBT to mindfulness-based stress reduction rather than usual care. One study showed no long-term effectiveness. Review of the evidence shows overall efficacy of CBT in patients without cancer. The intervention has been delivered effectively in person, individually or in groups, telephonically, and via the internet or videos.

The majority of evidence shows that CBT has a positive effect on sleep-wake disturbance in patients with cancer. The most effective duration, timing, and “dose” is unclear, but this approach appears to be effective when delivered with varied methods.

• This review does not provide a full report of search results or any method of quality evaluation of the studies included.  
• Reports individual study findings, but does not really synthesize and draw conclusions across studies

Evidence supports the effectiveness of CBT for sleep problems in patients with cancer, and this approach appears to be provided effectively in very practical ways, such as through videos and websites. At present, as reported in this review, CBT is seen as the treatment of choice for insomnia in patients with cancer. Future research for comparative effectiveness of various interventions for sleep disturbances is needed.

To examine the effects of a mindfulness-based stress-reduction therapy (MBSRT) on stress and mood disturbances and to examine the relationship of improved mindfulness and mood changes.

Hospital staff referred patients to the study or patients self-referred to the study. MBSRT consisted of eight weekly sessions and a six-hour silent retreat held after the sixth session. Classes taught participants about the mind-body connection, principles of mindfulness, and yoga practice. Patients were encouraged to share experiences to generate support from group members. All were given CDs with guided meditation exercises, and all received a program manual. Patients were encouraged to practice meditation and mindful movement at least 45 minutes per day. Patients who did not attend at least five sessions were excluded from the analysis.

• The sample was comprised of 268 patients.
• Mean age was 53.8 years.
• The sample was 15.7% male and 84% female; 71% were married or partnered.
• Patients were diagnosed with breast, hematologic, and colon cancer.
• Average time from diagnosis was zero years, indicating participation close in time to diagnosis.

• Single site
• Outpatient
• Canada

Patients were undergoing the transition phase after active treatment.

The study used a pre-/posttest design.

• Mindfulness Attention Awareness Scale (MAAS)
• Five Facet Mindfulness Questionnaire (FFMQ)
• Calgary Symptoms of Stress Inventory (C-SOSI)
• Profile of Mood States (POMS) Questionnaire

• The level of mindfulness increased significantly over the course of the program (p < 0.001). 
• Improvements in stress and mood outcomes were noted, with effects of at least small to moderate size.
• Change was observed in tension-anxiety (d = 0.52), depression (d = 0.44), and fatigue (d = 0.37) (p < 0.001). 
• The study revealed no significant or strong correlation between mindfulness change and mood change.

The findings supported the use of MBSRT approaches for managing the symptoms of anxiety, depression, and fatigue.

• The study had risks of bias:  the sample consisted mostly of self-referred participants, suggesting that participants may have been predisposed to find therapy effective; and the study lacked a control group, blinding, random assignment, and appropriate attentional control condition. The lack of a control condition is particularly important because anxiety, depression, and fatigue can improve over time with no intervention.
• The findings were not generalizable.
• Baseline anxiety and depression scores were not reported, so it is not known if patients had any initial significant mood problems.
• The authors stated that patients who did not attend at least five sessions were excluded from the analysis, but the authors did not report how many patients, if any, were excluded; therefore, the drop-out rate and final sample size were unclear.
• The fact that the study revealed no significant correlations between change in mindfulness scores and mood changes may suggest that the mindfulness aspect of the intervention may not be the main effective component—the component may have been yoga or the support group sessions.

The findings suggested that a stress-reduction intervention involving group support, yoga, and mindfulness may help patients manage the symptoms of anxiety, depression, and fatigue. The various study limitations prevented firm conclusions from being drawn.

This study was an evaluation of whether a diet including fresh fruits and vegetables increased the risk of infection in adult patients with cancer who were receiving induction chemotherapy for either acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) in a protective environment.

Patients were randomized to either a “raw group” (n = 75) that was allowed a general diet including fresh fruits and vegetables or to a “cooked group” (n = 78) that was restricted to a low-microbial diet of all cooked food but no fresh fruit or vegetables. Patients remained in a protective environment from the initiation of induction chemotherapy until recovery of the absolute neutrophil count (ANC) over 500 mcl.  

Patients received routine antimicrobial prophylaxis with levofloxacin, valacyclovir, and an antifungal agent (itraconazole, voriconazole, or lipid amphotericin B).

Granulocyte–colony-stimulating factor was not used routinely.

Endpoints for the study were pneumonia, bacteremia, major infection, fever of unknown origin, and death.

• A total of 153 patients were in the study.
• Patients were all newly diagnosed with either AML or MDS and received induction chemotherapy in a protective environment (with a high-efficiency particulate air-filtered room).
• Median age of the patients in the raw group was 63 years.
• Median age of the patients in the cooked group was 64 years.
• The most frequent chemotherapy used was cytarabine.
• One-third of the new patients (n = 53) refused to participate in the study and were placed in a nonrandomized group. They stayed on the low-microbial diet and were given a separate consent for chart review.

A single institution

The statistical design was the Bayesian multiple outcome design of Thall and Sung. The X2 or Kruskal-Wallis test was used to compare various pretreatment characteristics.

There was no statistically significant difference in the rate of infection, pneumonia, fever of unknown origin, or overall survival between the raw and cooked groups. A significantly higher rate of bacteremia was found in the raw group; however, the authors noted that most of the organisms responsible for the baceteremia were not of enteric origin.

The median number of days with an ANC less than 500 mcl was 20 days in the cooked group and 21 days in the raw group.
The median number of days with an ANC less than 100 mcl was 15 in the cooked group and 16 in the raw group.

• Major infection rates: raw group: 35%; cooked group: 29% (p = 0.6)
• Pneumonia rates: raw group: 5%; cooked group: 15% (p = 0.06)
• Bacteremia or fungemia rates: raw group: 23%; cooked group: 9% (p = 0.03)
• Fever of unknown origin rates: raw group: 36%; cooked group: 51% (p = 0.07)
• Rate of infection or fever of unknown origin: raw group: 76%; cooked group: 87% (p = 0.09)
• No significant difference existed in the rate of enteric organisms cultured from blood in either group (p = 0.12).
• Survival rates: raw group: 61%; cooked group: 56%; non-randomized: 64%
• Survival in all three groups was as expected in older patients with newly diagnosed AML or MDS.

A diet that includes raw fruits and vegetables did not increase the risk of infection or death in patients with MDS or AML treated with remission induction chemotherapy in a protective environment when compared to a diet that restricted raw fruits and vegetables.

One strength of the study is that the sample was a population of high-risk patients who had an ANC less than 500 mcl for a median of 20 days. In comparison, patients with solid tumors treated with chemotherapy are at low risk for infection, and the patients that experience neutropenia generally have an ANC less than 500 mcl less than seven days. Because this study demonstrated an absence of efficacy of the low-microbial diet in high-risk patients; it is unlikely to be of benefit in low-risk patients with a much shorter duration of neutropenia. However, further research is warranted to confirm the findings in other populations of neutropenic patients.

• The study was done at a single institution.
• The study was conducted with patients in a protective environment, and patients were treated routinely with prophylactic antimicrobial agents. Therefore, findings are not generalizable to outpatients, patients cared for in non-protective environments, or patients not treated with prophylactic antimicrobial agents.
• The rates of infection and death were the same between study groups; however, the rate of bacteremia was significantly higher in the raw group. Although the incidence of bacteremia was higher in the raw group, the authors reported that a substantial part of the difference reflected isolation of organisms not resident in the gut; the presence of such organisms would not be expected to be influenced by cooking of fruits and vegetables. In addition, the incidence of fever of unknown origin was higher in the cooked group, suggesting that some cases of bacteremia in the cooked group were not identified.

To confirm the potential therapeutic efficacy of PC6 stimulation by acupressure in patients with cancer experiencing chemotherapy-induced nausea and vomiting (CINV) after failure with pharmacologic approaches

PC6 acupoint was stimulated by acupressure with a button (P6 nausea control Sea-Band^®) for eight hours per day at home, starting before the onset of chemotherapy, and for at least three days after chemotherapy.

The study consisted of 100 consecutive patients with metastatic solid tumors admitted to receive chemotherapy for advanced disease.

Patients were included in the study if they had

• Histologically proven metastatic solid tumor.
• Measurable lesions.
• No double tumor or brain metastasis.
• No previous chemotherapy for metastatic disease.
• No concomitant illnesses other than cancer.
• Grade 3 or 4 vomiting.
• No response to conventional antiemetic therapies.

The study was conducted in Italy.

World Health Organization criteria were used.

Overall, 68% of patients achieved control of emesis.

No significant differences in efficacy were observed in relation to tumor histotype.

The percentage of efficacy varied in relation to type of chemotherapy. The lowest results were observed in patients treated with anthracyclines, whereas more benefit was seen in patients with other chemotherapy agents. However, the efficacy achieved was greater than 50% in the treatment of vomiting because of anthracyclines.

The study confirmed the efficacy of acupressure in the treatment of CINV with a larger number of patients than previously studied. Acupressure appears to be effective in reducing vomiting experienced as a result of most commonly used chemotherapy agents.

• Only vomiting was measured; nausea was not.
• This population was heterogeneous with different tumor types and chemotherapy agents.
• Antiemetics before and after chemotherapy were not described.
• No specific exclusion criteria were listed.
• Several questions arose related to the intervention: who taught the patients how to use the Sea-Bands; what training did that person have; and how, when, and who evaluated the effectiveness of the intervention.

To evaluate the safety and initial efficacy of acupuncture for the treatment of thalidomide and bortezomib-induced chronic peripheral neuropathy (PN)

Standardized acupuncture medication and equipment was used by two licensed acupuncturists three times per week for four weeks (one week of rest; two times per week for four weeks). Both upper extremities and both lower extremities had the same point sites of treatment. After participants experienced a sensation of numbness, tingling, or warmth at the needle insertion site, an electrical stimulation was applied bilaterally for 20 minutes after completion of 80% of treatment sessions.

• N = 19  
• AGE RANGE = 46–79 years
• MALES: 74%, FEMALES: 26%
• KEY DISEASE CHARACTERISTICS: Multiple myeloma 95%; amyloidosis 5%; for peripheral neuropathy (PN), all patients had symptoms in upper and lower extremities
• OTHER KEY SAMPLE CHARACTERISTICS: PN treatment, pain management, and prior therapy were allowed. Dose ranges and the number of months since last dose were recorded. Participants had Eastern Cooperative Oncology Group statuses < 2. Patients were allowed to remain on the same medication regimens for PN and pain. Minor adjustments to medications were allowed.

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: MD Anderson Cancer Center in Houston, TX, United States

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

Nonrandomized, pilot feasibility, safety and efficacy study with a quasi-experimental design

The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) were used to evaluate for PN prior to beginning the study. The General Functional Assessment of Cancer Therapy (FACT-G) and the Brief Pain Inventory Short Form (BPI-SF) were used to evaluate patient-reported outcomes and baseline and at weeks 4, 9, and 13 during the study. Objective measurements (coin test, button test, walking test, postural stability/fall risk) and bilateral tibial and sural sensory nerve conduction tests were conducted at baseline and at week 13. The FACT and Gynecologic Oncology Group-Neurotoxicity (GOG-NTX) scales were used to assess the primary thee endpoints for PN at baseline and at weeks 4, 9, and 13. Evaluable patients completed 80% of the study medication.

BPI-SF scores significantly improved in regard to pain severity with the worst pain occurring at 24 hours at all time points with large effect sizes in weeks 9 and 13. There was a significant improvement in BPI-SF pain interference in weeks 9 and 13 with a moderate effect size. FACT and GOG-NTX scores showed significant improvement in weeks 4, 9, and 13. Timed motor function tests from baseline to one month after the beginning of the study showed significant improvement. There was no statistically significant difference for fall risk, and nerve conduction studies demonstrated no change.

This feasibility, safety, and efficacy trial of electroacupuncture in 19 patients experiencing bortezomib- or thalidomide-induced PN demonstrated significant improvements in patient-reported outcomes for pain severity and interference according to the BPI-SF, FACT and GOG-NTX scores, and objective timed motor function tests from baseline to 13 weeks. No safety issues were reported.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Treatment group differences: Previous medications were 84% bortezomib versus 16% thalidomide. 68% of patients experienced grade 2 PN while 32% experienced grade 3 PN. At baseline, PN occurrences were 74% male and 26% female. 58% of patients were taking pregabalin and 32% were taking gabapentin; 41% of patients were taking opioids. The frequency of pain medication use during treatment was not measured. The nerve conduction studies that were performed were not reported. The method of assessment was not well described. The reliability and validity of tools was not reported.

The use of electroacupuncture requires additional study in large, randomized, controlled trials to establish safety, benefits, the duration and sustainability of benefits, and treatment recommendations as an adjunct therapy for bortezomib- and thalidomide-induced PN.

To evaluate the effectiveness of acupuncture for symptom control in patients with cancer.

Databases searched were MEDLINE, EMBASE, CINAHL, Cochrane Collaboration, Scopus, and PubMed through December 2011.

Search keywords were acupuncture, electroacupuncture, moxibustion, Chinese medicine, Asian medicine, and keywords that included cancer and cancer symptoms.

Studies were included in the review if they

• Were randomized, clinical trials (RCTs)
• Involved acupuncture with needle insertion
• Compared acupuncture to control, placebo, or sham acupuncture.

Studies were excluded from the review if they

• Compared two active acupuncture forms, acupressure, or other interventions similar to acupuncture that did not involve needle insertion
• Did not measure the effect of acupuncture on symptoms
• Were considered gray literature (i.e., not generally accessible).

In total, 3,494 references were retrieved and evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions.

• The final number of studies included was 41.
• The authors did not provide the sample range across studies, total number of patients, disease types, or characteristics.

Studies addressed potential management of the following symptoms:

• Pain:  Eleven RCTs met the criteria for analysis. No large trials reported positive results or were of good quality.
• Chemotherapy-Induced Nausea and Vomiting (CINV):  Eleven RCTs met the criteria for analysis. One large study with a low risk of bias showed between-group effect sizes for acupuncture versus sham (0.80) and for acupuncture versus usual care (1.10).
• Fatigue:  Three RCTs met the criteria for analysis. All had high risks of bias, and two had negative outcomes.
• Hot Flashes:  Seven RCTs met the criteria for analysis. None had a low risk of bias.
• Anxiety or Depression:  Five of the six RCTs analyzed showed positive results. All five had high risks of bias.
• Sleep:  Three RCTs met the criteria for analysis, and all three reported positive outcomes and had high risks of bias.

The strongest evidence that the study produced showed that acupuncture may be effective for the management of CINV. The study did not show acupuncture to be efficacious in the treatment of other symptoms.

The studies included were of low quality.

Available evidence, which was limited, did not support the claim that acupuncture is effective in alleviating various adverse symptoms in adults with cancer. Additional research is needed to determine the efficacy. The findings of this analysis suggested that patients with uncontrolled CINV may be appropriate candidates for acupuncture referral. For the treatment of other symptoms, the efficacy is undetermined.