To report the experience with a new technique, axillary reverse mapping (ARM), in patients scheduled for axillary lymph node dissection (ALND) and to evaluate its usefulness for reducing the incidence of lymphedema

For the intervention group, blue dye was injected subcutaneously along the intermuscular groove of the upper inner arm; radioisotope was injected subcutaneously in the interdigital webspace of the hand. All blue and radioactive lymph vessels and lymph nodes were recorded. Only unsuspicious ARM lymph nodes located in the lateral part of the axillary basin were preserved. All other level I and II axillary lymph nodes were removed. One follow-up was conducted at a median of 19 months.

• N  = 143 
• MEDIAN AGE = 58 years
• AGE RANGE = 29–88 years
• MALES: 2.1%, FEMALES: 97.9%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer undergoing ALND

• SITE: Single site 
• SETTING TYPE: Inpatient 
• LOCATION: Brust-Zentrum Zurich, Switzerland

• PHASE OF CARE: Mutliple phases of care

• Pre-post design

• Arm volume measured using water replacement method via an arm volumeter

ARM was performed in 143 patients subsequently undergoing ALND. ARM lymph nodes were successfully identified in 112 patients (78%). In 55 patients, at least one ARM lymph node had to be removed. In 14 of these, tumor involvement was confirmed. In 71 patients, one or more ARM nodes were preserved. During a median follow-up time of 19 months, no axillary recurrence was noted. Thirty-five of 114 evaluated patients developed lymphedema. Preservation of ARM lymph nodes did not significantly decrease the incidence of lymphedema

ARM is feasible for patients with node-positive breast cancer. However, the study found no evidence that it reduces the incidence of lymphedema.

• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Other limitations/explanation: Single0site study, non-RCT design, no baseline arm volume measure, and borderline power of the sample size

Larger studies with rigorous design are needed to evaluate whether preservation of clinically unsuspicious ARM nodes is oncologically safe and effective in preventing secondary lymphedema in patients with breast cancer.

Determine whether treatment with calcium channel blockers prevented oxaliplatin-induced acute neuropathy

Retrospective chart review was conducted to obtain data, and analysis was performed to determine differences in neuropathy symptoms between patients who were and were not on calcium channel blockers.

• N = 69  
• MEAN AGE = 62 years for the control group and 70 years for the intervention group
• MALES = 100%
• KEY DISEASE CHARACTERISTICS: Colorectal cancer; no staging data provided
• OTHER KEY SAMPLE CHARACTERISTICS: 35% of patients in the calcium channel blocker group were diabetic.

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

PHASE OF CARE: Active antitumor treatment

Two-group,  retrospective, cross-sectional

• Acute neuropathy charts were reviewed for symptoms of acute neuropathy including cold hypersensitivity, perioral paresthesias, shortness of breath, difficulty swallowing, pharyngolaryngeal dysesthesia, throat and jaw tightness, and dysphonia.
• Chronic neuropathy was evaluated using change of chemotherapy schedule and addition of supplementary analgesics.

The incidence of acute neurotoxicity was lower in the calcium channel group; however, no differences existed related to chronic neuropathy.

Patients receiving calcium channel blockers may experience less acute neurotoxicity than those not receiving calcium channel blockers, but more well-designed studies are needed before any conclusions can be made.

• Measurement validity/reliability was questionable.
• Study design was retrospective.
• Study primarily focused on acute oxaliplatin-induced neurotoxicity, which is a unique side effect of oxaliplatin and distinctly different from chemotherapy-induced peripheral neuropathy, which is chronic and has a different presentation and trajectory.
• Patients were already on calcium channel blockers when they enrolled in the study.

More studies are needed before any clinical implications can be made.

To determine effectiveness of cognitive behavioral therapy (CBT) techniques in alleviating distress and pain in patients with breast cancer

• Databases searched PsycINFO, MEDLINE, CancerLIT, and CINAHL 1974–June 2004. Investigators completed manual searches of reference lists and published meta-analyses.
• Search keywords were anxiety, cognitive behavioral therapy, distress, depression, hypnosis, imagery, pain, relaxation, and treatment outcomes.
• Studies were included in the review if they
  • Were randomized controlled trials (RCTs) with no-treatment or standard-care controls
  • Provided data sufficient to allow calculation of effect sizes
  • Measured pain and distress
• Studies were excluded if they did not measure pain directly.

The search retrieved 61 studies. Investigators eliminated some on the basis of the exclusion criterion; meta-analysis involved 20 studies. Authors defined CBT very broadly: Interventions included relaxation; guided imagery; hypnosis; biofeedback; and approaches combining cognitive restructuring, skill trainingt, and other strategies to enhance problem solving and coping. Authors do not describe the specific procedure used to evaluate study quality.

• Across the 20 studies, the sample was composed of 1,703 patients. Sample range was 16–215 patients.
• Seven studies were included in the meta-analysis regarding interventions for pain. All patients in these seven studies, 474 patients over all, had breast cancer.

Authors noted that 69% of patients in treatment groups did better than controls with respect to pain. Regarding pain, effect size (d) was 0.49 (95% CI 0.09–0.90, p < 0.05). Subgroup analysis comparing individual versus group interventions showed that intervention format had no effect on pain.

Findings suggest that CBT techniques produced a small to medium effect, as defined by the study, regarding the reduction of the pain of women with breast cancer.

• Authors defined CBT very broadly, including such techniques as hypnosis and relaxation therapy, which would not usually be considered CBT approaches.
• The number of studies and overall sample size for analysis regarding pain was relatively small. Authors did not report heterogeneity.
• Though effect size was statistically significant, whether a reduction of 0.49 on a pain scale is clinically meaningful is unclear.

Findings suggest that, for women with breast cancer, CBT may be a helpful adjunct to pain management. This finding is limited by the broad definition of CBT that this study employed. This study determined effect size on the basis of statistics. Future studies should define the type of change that is meaningful to patients—that is, change in symptoms.

To compare the safety profiles, adverse effects, and patients' preferences regarding slow-release oral morphine and transdermal opiates

• Databases searched were MEDLINE and EMBASE, January 1966–June 2006.
• Search keywords were administration, cutaneous (in subject headings); analgesic, opioid/*administration, and dosage adverse effects (in subject headings); and fentanyl, buprenorphine, cancer pain/*drug therapy (as main terms).
• Studies were included if they
  • Were randomized controlled trials at phase III.
  • Included subjects with moderate to severe cancer pain and who had a defined opiate need at study entry.
  • Compared slow-release oral morphine to transdermal opiates.
• Studies were excluded if information about randomization was inadequate, the study did not report safety data, the sample included patients who needed opiate titration at study entry, or the study used historical controls or was a phase 2 trial.

• The search retrieved 117 studies. Twelve studies were considered potentially eligible. Four were included in analysis.
• Authors evaluated study quality by means of the Jadad scale. Two of the studies were of low quality, with a Jadad score of 2 or less.

• The sample for meta-analysis consisted of four studies, which included 425 patients. Of the 425 patients, 188 were treated with transdermal fentanyl and 26 received buprenorphine.
• The range of sample size was 47–202 patients.

• Comparison of overall adverse effects showed no heterogeneity and no difference between treatments (odds ratio [OR] 0.789, p = 0.465).
• Compared to oral slow-release morphine, transdermal opiates seemed better at reducing constipation (OR = 0.38, p < 0.001). Authors noted no differences or heterogeneity in other adverse events.
• Authors analyzed adverse events overall as well as individually. Adverse events included constipation, diarrhea, anorexia, nausea, vomiting, insomnia, somnolence, confusion, headache, and vertigo.
• Patient preference data showed that patients favored transdermal opiates (OR = 0.43, P = 0.014).

Compared to slow-release oral morphine, transdermal opiates were associated with fewer cases of constipation. Patients tended to prefer transdermal opiates to slow-release formulations.

• This meta-analysis had a small sample size.
• Of the four studies in the meta-analysis, the quality of two studies was low. View findings with caution.

Compared to slow-release oral morphine, transdermal opiates appear to be associated with fewer cases of constipation; transdermal opiates may be a better alternative for pain control in patients with constipation. This review suggests that patients may prefer pain medication via the transdermal route. Clinicians should consider constipation and preference in individualizing pain management.

To compare transdermal fentanyl to slow-release oral morphine—in terms of safety, efficacy, and patient compliance—in patients who have stable opiate requirements for pain control

• Databases searched were MEDLINE and EMBASE (January 1966–June 2007).
• Search keywords were Medical Subject Headings (MeSH) terms for cutaneous administration, oral administration, analgesic opioid administration and dosage/adverse effects, delayed action preparations, fentanyl, cancer pain, drug therapy, low back pain/drug therapy and morphine administration, dosage, and adverse effects.
• Studies were included in the review if they
  • Were randomized controlled trials.
  • Reported mature phase III trial data.
• Studies were excluded if they were nonrandomized trials.

Of the 117 trials retrieved, 11 were considered potentially eligible. The analysis included five trials. Three trials included patients with cancer, and two included patients without cancer. The quality of the reports was evaluated using the Jadad scale.

• The studies reported on a total sample of 1,309 patients across all trials.
• The sample included 652 patients who were treated with transdermal fentanyl and 657 who were treated with slow-release oral morphine.
• The sample included 373 patients who were treated for cancer pain.
• In some trials, patients were in palliative care programs.

• Compared to slow-release oral morphine, transdermal fentanyl was associated with less constipation, urinary retention, and laxative use, as well as higher patient preference.
• Slow-release oral morphine was associated with less nausea, diarrhea, and sweating.
• Authors observed no significant differences between the two drugs in regard to overall safety or gastrointestinal safety, somnolence, anorexia, vomiting, hypoventilation, insomnia, or uncontrolled pain that called for opiate rescue doses.
• Findings were stable following analysis of cancer and noncancer subgroups.

Side-effect profiles of transdermal fentanyl and oral slow-release morphine differ, but in this analysis authors observed no significant differences in overall side effects and patient preference regarding the two approaches. Transdermal fentanyl appears to be a valid alternative to oral opiates.

• The analysis included a small number of studies.
• Two trials included in this evaluation were of low quality.
• Not all trials used the same methods of equianalgesia.

Findings should be interpreted with caution, given the limitations of this meta-analysis. Additional research comparing transdermal and other medication delivery routes for pain control is warranted. Transdermal opiates may be particularly useful for patients using opiate switching. Addressing individual patients' needs and concerns may mean that side-effect profiles play an important role in the selection of a medication delivery route.

To evaluate the effect of a wristband acupressure for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancers

Patients completed diaries daily for five days while they were receiving chemotherapy. Based on their treatment protocol, patients received a wristband 21 to 28 days later, along with written and verbal instructions and demonstration on its use. Patients were instructed to wear the wristbands constantly and to complete the patient diaries for the five days while receiving chemotherapy. On the sixth day, patients completed questionnaires about the wristbands. All patients received standard antiemetics and recorded medication use in their diaries.

• The study consisted of 34 patients.
• The mean age of patients was 50.55 ± 10.55 years, with a range of 24–69 years.
• All of the patients were female.
• The majority of patients (76.5%) had ovarian cancer, with the balance having cancer of the endometrium, cervix, or fallopian tubes (23.5%).
• The majority of patients (85.3%) had completed primary/middle school, and 14.7% were high school/university graduates.
• Nearly half (47%) of patients had or were experiencing motion sickness, and 65.6% had histories of nausea or vomiting during the first months of pregnancy.
• Patients were receiving different chemotherapy regimens, but all were receiving carboplatin along with various other chemotherapy (cisplatin + cyclophosphamide, cisplatin + paclitaxel, doxorubicin, or docetaxel).

The study was conducted at multiple outpatient sites in Turkey.

All patients were in active treatment.

This was a prospective clinical trial with a pre/post-test design.

• Sociodemographic information and medical histories were recorded.
• Patients recorded nausea severity on a 0–10 scale (0 for no nausea; 10 for very severe nausea) in diaries and completed wristband questionnaires.
• Vomiting, retching, number of antiemetics taken, and amount of time the wristband was worn were recorded on graphs.

• Mean nausea significantly decreased after wristband use compared to before wristband (p = 0.000).
• No significant difference was noted in vomiting or retching.
• The mean use of antiemetic medication with wristbands was significantly less than before wristbands (p = 0.000).

Acupressure wristbands worn by patients with gynecologic cancers during chemotherapy administration were associated with a significant reduction in nausea but not vomiting or retching. Less antiemetic medication was used with the acupressure wristband.

• The sample was small with fewer than 100 patients.
• The majority of patients had less than a high school education, which may have influenced the information recorded in the patient diaries. 
• Patients may have over- or underestimated the time they wore the acupressure wristband.
• A placebo effect could have arisen with patients expecting any treatment would reduce their symptoms, especially since the time of wristband use had no effect on outcome measures.
• How delayed nausea was defined and analyzed was not clear, because patients recorded their symptoms only during their chemotherapy treatment.
• How often or when the nausea and vomiting measurements were recorded was not clear.
• No reliability or validity information was provided for any of the tools used.

Acupressure wristbands may provide some relief of nausea during chemotherapy treatment; however, they do not appear to provide relief from retching or vomiting.

To examine the effectiveness of an eight-week yoga program on depression, anxiety, and fatigue in women undergoing adjuvant chemotherapy for breast cancer

Patients were randomized to yoga and control groups. Control group patients received usual care and maintained ordinary daily activity routines. The yoga group had 60-minute sessions including meditation and breathing exercise, yoga exercises, and a cool-down. The program was provided twice per week over eight weeks. Study measures were obtained at baseline, at week 4, at week 8, and at four weeks after the conclusion of the intervention. It is not clear if yoga sessions were provided in a group setting or what the timing was related to chemotherapy treatments.

• N = 60  
• MEAN AGE: Age and range not provided; about 50% were below or above 50 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All participants had breast cancer and were receiving adjuvant chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: 45% had a high school education and 33.3% had a university-and-above education 

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Brief Fatigue Inventory (BFI)
• Profile of Mood States (POMS)

Fatigue level and its influence on daily life were lower in the experimental group after eight weeks, which was maintained at three weeks postintervention (p < .001). In the control group, the fatigue level increased after eight weeks (p < .001). In the control group, the influence of fatigue on daily life initially declined but increased from baseline after eight weeks. In those participants with higher baseline fatigue levels, in the first four weeks, benefits were fewer in the experimental group. There were no differences between groups in anxiety or depression. Participation in the yoga sessions was 90% overall.

Yoga participation was associated with improvement in fatigue and the influence of fatigue on daily activities after four weeks. Yoga had no effect on measures of anxiety or depression.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)

Yoga can be beneficial for patients to reduce fatigue during active treatment as shown in this study. Findings that those with higher fatigue scores did not show fatigue reduction until after four weeks suggest that patients with greater fatigue may need a longer program than others to derive full benefits. There was no apparent effect of participation in yoga sessions on anxiety or depression.

To examine the effectiveness of IV administration of paracetamol on the control of cancer pain and its possible contribution as reduction of opioid consumption

Patients were randomized to receive IV administration of saline (control) or 1 g of paracetamol on top of morphine.

• The study reported on a sample of 43 patients.
• Patient age range was 18–76 years. 
• Patients had chronic cancer pain without neuropathic origin; all had either somatic or visceral pain, but none had both types of pain.
• Patients had a visual analog scale (VAS) score of greater than 4, a Pain Rating Index (PRI) score greater than 10, and an Eastern Cooperative Oncology Group (ECOG) performance status score of less than 3.

• Single site
• Outpatient setting
• Pain clinic of Istanbul University

The study was double-blind, placebo-controlled, and randomized.

• VAS
• PRI
• ECOG performance status
• Statistical Package for Social Sciences (SPSS)
• Two-way ANOVA
• Chi-square test and Fisher’s exact test
• Paired sample t test
• Student t test
• Mann-Whitney U test or Wilcoxon sign test

Both treatments resulted in improved VAS and PRI scores compared to baseline. However, groups did not differ in terms of VAS and PRI scores, morphine consumption, side-effect frequencies, laboratory values, ECOG stats, and patient satisfaction. The study failed to confirm any benefits of add-on treatment with IV administration of paracetamol.

There was no benefit derived from adding IV paracetamol to morphine in an effort to enhance the effectiveness or contribute to reduction in opioid consumptions.

The study had a small sample.

This study further supports the growing body of evidence that adding paracetamol to an opioid does not necessarily improve pain control or minimize the need for opioid. Pain management needs to be individualized. Further study in this area is warranted.

To investigate the effects of acupuncture on nausea, vomiting, pain, sleep quality, and anxiety in patients who were hospitalized or undergoing chemotherapy

Acupuncture was given for three days. On the day of hospitalization and after three days, study assessments were completed. Chemotherapy-induced nausea and vomiting (CINV) was not measured in patients receiving chemotherapy for the first time.

• N = 45
• MEAN AGE = 50.5 years (SD = 13.3 years)
• MALES: 60%, FEMALES: 40%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; 71% were receiving palliative chemotherapy; 29% were receiving adjuvant chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: 70% received primary school or less education

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

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

• Quasi-experimental

• Visual Analog Scale (VAS) for pain
• Insomnia Severity Index (ISI)
• Nausea and vomiting were measured according to oral intake and graded on a 0–4 scale.
• Beck Anxiety Inventory (BAI)

The sign test was used to show the pre- and post-treatment significance of differences, and these were shown for all symptoms (p < 0.001). However, the pretreatment score for insomnia was equal to one before and after treatment, and a larger proportion of patients did not improve (57.8%) than improved (42.2%) in terms of sleep quality. In other symptoms, the percentage that improved was similar to the percentage that did not improve. The intervention group appeared to have the greatest number of patients whose nausea improved.

Acupuncture may be a useful adjunctive therapy for the management of pain, CINV, anxiety, and insomnia in hospitalized patients receiving chemotherapy. The design of this study limits the strength of its findings.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: No information was provided regarding the use of other interventions such as medications for any of the symptoms examined. Baseline symptom levels were not reported in all cases.

Acupuncture is a complementary therapy that may be beneficial as an adjunct treatment for symptom management in patients with cancer. This individual study has multiple limitations, and additional evidence is needed to evaluate the effectiveness of acupuncture.

To determine the efficacy of docusate in patients in hospice

Patients were randomly assigned via a code generated by a public domain computer. Randomization was assigned by a pharmacist, and the research assistant, patient, proxy, attending physician, and nurses were blinded to study treatment. The intervention group received two 100 mg docusate tablets in the morning and late afternoon plus one to three sennoside tablets (8.6 mg per tablet) one to three times per day. The placebo group received two cornstarch tablets in the morning and afternoon in addition to one to three sennoside tablets (8.6 mg per tablet) one to three times per day. All medications were administered by hospice nursing staff for a period of 10 days. Docusate pills were rolled in cornstarch and placed into nontransparent blue capsules, and the placebo pills were only cornstarch in blue capsules so that both the intervention and placebo pills looked the same. All patients were allowed to take laxatives and receive other bowel interventions as needed throughout the study. Nurses received multiple education sessions on stool consistency and volume to ensure inter-rater reliability. Nurses recorded data daily for 10 days.

• N = 74
• AGE = ≥ 18 years 
• MALES: 55%, FEMALES: 45%
• KEY DISEASE CHARACTERISTICS: Cancer and non-cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Palliative Performance Scale (PPS) score and Mini-Mental State Examination (MMSE) score of 23

• SITE: Multi-site  
• SETTING TYPE: Inpatient  
• LOCATION: Edmonton, Alberta, Canada

• PHASE OF CARE: End of life care
• APPLICATIONS: Elder care, palliative care

Randomized, double-blind, placebo-controlled study

• Assessment and recording of bowel movements, which included stool frequency and volume, stool consistency, constipation symptoms, and ease with which defecation occurred.
• Type/frequency of other bowel interventions
• Patient perception of completeness of evacuation
• Edmonton Symptom Assessment System (ESAS)
• Bowel movement record

The results revealed no significant difference in stool frequency, volume, or consistency between the two groups. Data showed no significant differences in patients’ perception of the difficulty or completeness of defecation. ESAS scores showed no difference in symptoms experienced between the two groups. No difference was seen in the number of additional bowel-care interventions provided to patients in this study.

There were no significant differences between the docusate group and the placebo group, suggesting that the use of docusate should be considered on a patient-by-patient basis.

• Small sample (< 100)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable

Nurses must assess patient needs versus what is actually happening. Frequent abdominal inspections should be made with or without the use of docusate. Other things that should be assessed include bowel sounds and pattern of bowel function as well as the color, consistency, and amount of stool produced without regard to docusate use.