To assess the efficacy of kinesiology taping (KT) for treating breast cancer-related lymphedema

Participants were randomly assigned to the KT group (K-tapes), quasi-KT group (bandages), or multilayered compression therapy (MCT) group. Subjects from all groups received a routine treatment, including skin care, 45-minute pneumatic compression therapy with a DL1200 device (at a pressure of 90 mmHg, 12 chambers arm overlapping cuff, hold time three seconds with no interval), one hour of manual lymphatic drainage, and the application of multilayered short-stretch bandages (50–60 mmHg).

Each of the groups were treated three times weekly (bandages or K-tapes were applied and changed on Mondays, Wednesdays, and Fridays) in the four-week intervention period.

Limb volume measurements (both affected and healthy upper limbs) were taken for all three groups before and after therapy.

• N = 65  
• AGE RANGE = 39–81 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Unilateral breast cancer-related lymphedema for at least one year; moderate to severe lymphedema (stages 2 and 3 of upper limb edema with the volume difference between the affected and healthy extremities greater than 20%); no chemotherapy or radiation therapy for at least six months; and good compliance and willingness to sign the written consent form 

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Poland

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Pediatrics

Randomized, single-blinded, controlled trial

• Limb volume was measured by an optoelectronic Perometer 40 T cooperating with a personal computer.

All three groups experienced a reduction in volume, KT (p = 0.002), quasi-KT (p = 0.002), and MCT (p = 0.000001). There were no significant differences in changes in arm volume between the KT group and the quasi-KT group. The edema reduction of MCT was much better than in the taping groups.

This single-blinded, controlled pilot study did show that K-tape is effective in releiving secondary lymphedema after breast cancer treatment.

• Small sample (< 100)
• Subject withdrawals ≥ 10%

The study findings indicated that there is not enough evidence for using K-tape to replace bandages. Well-designed studies with larger sample sizes examining the effectiveness of K-tape for patients with breast cancer and arm lymphedema are needed.

STUDY PURPOSE: To evaluate the literature on the effectiveness of low-level laser therapy (LLLT) on pain and swelling secondary to breast cancer–related lymphedema (BCRL)

TYPE OF STUDY: Systematic review and meta-analysis

• FINAL NUMBER STUDIES INCLUDED = 9
• TOTAL PATIENTS INCLUDED IN REVIEW = 289
• SAMPLE RANGE ACROSS STUDIES: 10–64, although it states “8–64” on page 297
• KEY SAMPLE CHARACTERISTICS: All subjects were adult female breast cancer survivors with BCRL. Limb volume criteria for the study participants included 200 ml or more interlimb difference, more than a 2 cm difference between limbs at multiple measure points, or % difference between limbs.

PHASE OF CARE: Multiple phases of care

Pooled effect sizes (ESs) and 95% confidence intervals were used with nine eligible studies with evidence levels of 2–4 compared the effectiveness of LLLT both alone or with other treatment regimens for BCRL. ESs were calculated for pain and volume of the affected upper extremity. Within-group pooled ES for volume from six studies reported a 75.7 ml volume reduction post-LLLT and a between-group pooled ES for volume from four studies of 90.9 ml reduction with treatment that included LLLT. Within-group pooled ES for pain from two studies resulted in a 13.5 mm reduction of pain using the visual analog scale ([VAS], 0–100 mm). Between-group pooled ESs for pain from two studies were not statistically significant.

A systematic review and meta-analysis of nine studies reported with moderate strength evidence that within-group clinically relevant limb volume reductions were greater with the use of LLLT than without immediately following LLLT. The same was reported regarding clinically relevant pain associated with BCRL. Two studies are identified as not having a comparison group, and statistical reporting varied between the studies, making the ES pooling difficult.

• Low sample sizes
• Not all treatment groups received LLLT
• Non-LLLT treatments varied
• Laser types, application duration, and number of sessions of LLLT varied.
• Patient characteristics, such as age and comorbidities, were not reported.
• Varied methods of measure for limb volume were used, and only five studies included measures for pain.

It is important for nurses to understand the use of systematic reviews and meta-analyses in helping to improve evidence-based findings. Nurses can help establish clinical relevance or clinical significance benchmarks, as well as identify variables that may impact results. These findings suggest that LLLT may be helpful in the management of lymphedema; however, additional research is needed in this area.

To determine the effects of vigorous cardiorespiratory exercises on upper extremity limb volume in women with breast cancer-related lymphedema (BCRL)

In this study, 133 women with a history of breast cancer were enrolled. Patients were grouped according whether or not they had BCRL (63 had a previous diagnosis of lymphedema). There was one single intervention of cardiorespiratory exercise on a treadmill. Participants gradually increased the intensity of the exercise until they requested to stop or the test monitor recommended it. Participants’ upper extremities were measured using bioimpedance spectroscopy before and after treadmill exercise. They were instructed to have no food or fluid within one hour of their appointment, no exercise for 24 hours prior, and to avoid alcohol in excess for 12 hours prior. Initially, participants rested for 10 minutes on the table in a supine position. Their arms were measured every 10 cm from the wrist before treadmill exercise. Patients with lymphedema used compression garments if this was their practice.

• N = 133  
• AVERAGE AGE = 56.27 years (SD = 9.38 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer status at least six months postoperatively for unilateral breast cancer surgery; with or without BCRL; no active cancer; no cellulitis; excluded if they had absolute contraindications to exercise testing from the American College of Cardiology or American Heart Association or American College of Sports Medicine
• OTHER KEY SAMPLE CHARACTERISTICS: English speaking; aged 18 years or older

• SITE: University of California San Francisco Clinical and Translational Science Institute Research Center
• SETTING TYPE: Research center at a university 
• LOCATION: San Francisco, CA

• PHASE OF CARE: Late effects and survivorship

Cross-sectional study of 133 women divided into two groups (63 with and 70 without BCRL)

• Bioimpedance spectroscopy
• Resistance ratios (RRs): Unaffected or affected before and after treadmill exercise
• Oxygen consumption measured by peak VO2 (highest level of oxygen consumption during testing)
• Hemodynamics: Peak responses were made for heart rate, blood pressure, and rated perceived exertion
• 12-lead electrocardiogram was monitored continuously
• Circumferential arm volume: Measurements taken every 10 cm starting from the wrist (calculated using the formula for a truncated cone) before treadmill exercise only.  

This study only evaluated the immediate effects of one symptom-limited treadmill test on arm volume in women with and without BCRL. In addition, the inconsistency in the use of a compression sleeve, as well as the different durations and degrees of lymphedema, creates some confounding results. More research efforts with rigorous designs are needed to examine the effects of cardiorespiratory exercise on arm volume in women with and without BCRL.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

There is confusion regarding what type of exercise patients with BCRL should do. This research leans towards encouraging cardiovascular exercise, but additional research is needed. At this time, recommending a sleeve for all patients might be warranted.

Evaluate the impact on chemotherapy-induced peripheral neuropathy (CIPN) associated with the MC5-A Calmare^® therapy device.

Participants were recruited from the clinical oncology practice by physician referral and advertisements in the waiting rooms. The MC5-A device was applied daily to areas of CIPN determined and assigned to dermatomes. The treatment time was 60 minutes for 10 days. The MC5-A device is intended to induce modulation of pain responses with low frequency simulation to nerves with surface electrodes, raising the “gate” threshold for pain at the spinal cord. Patients were evaluated at baseline and at the end of weeks 1 and 2 of treatment, and then at the end of weeks 4, 8, and 12. Subjects rated their pain immediately before and after treatment.

• N = 16 (were evaluable)
• MEAN AGE = 58.6 years (SD = 10.6 years)
• MALES = 22%, FEMALES = 77%
• KEY DISEASE CHARACTERISTICS: The most frequent diagnoses were breast and colon cancer. The most common chemotherapy drugs that were used were taxanes, platinum, and bortezomib. All subjects had unstable CIPN for at least three months.
• OTHER KEY SAMPLE CHARACTERISTICS: Ten subjects were Caucasian, 6 were African American, 1 was Native American, and 1 reported \"other.\" Ten patients were previously treated for pain with opioids; 4 were treated with gabapentin monotherapy; and others were treated with various drug combinations.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Massey Cancer Center, Virginia Commonwealth University, in Richmond, VA

• PHASE OF CARE: Active treatment
• CLINICAL APPLICATIONS: Late effects and survivorship

Prospective study

• Pain numeric rating scale (for pain right now) 
• Quality of life measured by The Uniscale
• Change in use of pain drugs
• Toxicity measured by the Cancer Therapy Evaluation Program, North Central Cancer Treatment Group Symptom Experience Diary

Fifteen of the 16 subjects reported a 20% reduction in their pain score by the end of the study. The pain score was reduced 59% from 5.81 pre-treatment to 2.38 at the end of the 10 days ( P < 0.0001 by paired t-test ). The daily reduction in pain score was 1.02 during the 10 days of treatment. After treatment was discontinued, pain scores returned to pretreatment levels. No changes in opioid doses occurred during the course of the study, with patients on average receiving 110-150 oral morphine equivalents per day. There were no changes in quality of life or symptoms (as evaluated by the Symptom Assessment Diary).

Although 15 of 16 patients experienced a reduction in their pain, drawing any significant conclusions is difficult with such a small sample in a prospective study.

• Small sample of less than 30
• Single site
• Not a randomized, double-blind study
• Short-term follow up period
• There was no discussion of changes in any non-opioid or coanalgesic medications for pain.
• Although the authors reported no changes in daily opioid intake during the study, it is not clear how this was determined.
• Changes in pain were measured only immediately pre- and post-intervention, so it is not clear if any effect occurred during the day other than immediately after the treatment.

MCA-5 therapy required patients to return to the clinic daily for 10 days post-treatment. This expectation may be impractical for many patients. Also, not all facilities would have someone available and skilled to do the procedure. The cost of the therapy could be an issue as well. Further research is needed to evaluate the potential benefits of this type of therapy, and longer term follow-up is needed. Consideration of background medications for pain in analysis of results is important for subgroup analysis. Research in this area using a sham-controlled procedure would be helpful to rule out placebo effect.

To examine the effects of therapeutic massage on pain, sleep quality, symptom distress, and anxiety in patients hospitalized for treatment of cancer

Patients who received massage had 15–20 minutes of light Swedish massage techniques of effleurage and petrissage three times during one week of hospitalization. Each session was given at least 24 hours apart. The control condition was 20 minutes of deliberate focused communication from a nurse. Discussions involved patient teaching, relaxation techniques, questions about cancer and treatment, life challenges, and stress reduction.

• The sample was 40 hospitalized patients with cancer.
• Mean patient age was 62 years; range was not provided.
• The sample was 95% male and 5% female.
• Various cancer diagnoses were included: lymph, lung, gastrointestinal, genitourinary, head and neck, leukemia, breast, and skin.
• The majority of patients were Caucasian, married or partnered, and not working.

• Single site
• Inpatient setting
• Colorado

Active treatment phase

A quasi-experimental design was used.

• Numeric Pain Rating Scale
• Verran and Snyder-Halpern Sleep Scale
• McCorkle Symptom Distress Scale
• Spielberger State-Trait Anxiety Inventory

• Analysis of variance showed changes in pain and symptom distress in the group receiving massage (p < 0.10), and in sleep in the control group (p < 0.10).
• There was no difference in anxiety.

Provision of therapeutic massage in hospitalized patients with cancer may have a positive effect on pain and symptom distress.

• The study had a small sample, with less than 100 participants.
• Because the study had no random assignment and no blinding, there is associated risk of bias.
• No information was provided on differences in use of pain medication or other interventions to control symptoms and relevant distress.
• The sample was biased, being mostly male and Caucasian.
• No information was provided about severity of illness.
• It is not clear whether the hospitalized patients were currently receiving chemotherapy or radiation therapy during hospitalization.

This study did not provide any strong support for the use of therapeutic massage in hospitalized patients with cancer.

A trained registered nurse (RN) provided 15 to 30 minutes of the light Swedish technique of effleurage and petrissage three times per week in the patients' hospital beds; sessions were 24 hours apart and at different times of the day and evening. The control group received 20 minutes of deliberate, focused communication. Outcomes were pain, sleep, symptom distress, and anxiety.

• The sample was comprised of 41 patients with cancer.
• Patients had leukemia, lymphoma, lung, gastrointestinal, genitourinary, head and neck, breast, and skin cancers.

• Inpatient
• Veteran’s administration hospital
• Midwestern United States

Patients were undergoing the active treatment phase of care.

The study used a quasiexperimental design, with pre- and postintervention comparison groups:  one arm received massage and the other was the control arm.

Verran and Snyder-Halpern Sleep Scale (VSH)

Sleep quality remained the same.

• The study had a small sample size and lacked random assignment to groups. Cohorts were treated sequentially.
• The sleep scale was not tested for validity and reliability with polysomnography.
• The RN must be trained in massage techniques.

To evaluate whether implantable drug delivery systems (IDDS) could help the most refractory patients failed by expert comprehensive medical management (CMM)

This was an RCT of IDDS (starting with morphine, but changing to a different drug if ineffective) plus CMM versus CMM alone in 200 patients with refractory cancer pain. Patients were randomized to CMM or IDDS. Clinical success was defined as a 20% reduction of pain regardless of toxicity or a 20% reduction of toxicity without a resulting increase in pain. A more stringent measure was a 20% reduction in both pain and toxicity. Results were obtained from weeks 4 and 12.

• N = 99 patients in the group (66 CMM only, 30 CMM plus IDDS)
• AGE: CMM only = 44–72 years; CMM plus IDDS = 32–69 years
• MALES: CMM only = 62.3 % males; CMM plus IDDS = 53.3% male
• KEY DISEASE CHARACTERISTICS: Patients had cancer. Cancers include lung, breast, prostate, colon, and pancreas.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had a visual analog scale (VAS) score of 5 or more despite pain management, were taking at least 200 mg oral morphine or equivalent, and had at least three months to live.

• RCT with crossover for clinical failure (pain 5 or more, limiting side effects, approved by investigator)

• VAS and National Cancer Institute Cancer Therapy Evaluation Program (CTEP) scales
• Composite drug toxicity score
• CMM measured by “Management of cancer pain: A quick reference guide for clinicians” (Agency for Health Care Policy and Research, 1994)

CMM patients who crossed to IDDS for the most refractory pain had a significant reduction in pain and drug toxicity. Patients who failed CMM and crossed to IDDS had a 27% reduction in pain scores and a 51% reduction in toxicity. Patients who failed CMM had a 20% reduction in pain, but pain was moderate to severe, while their opioid toxicity increased by 22%. Survival was improved in patients who received IDDS much earlier. Side effects and complications of IDDS were minimal, and there were no pump removals or infections.

Even the most refractory patients can have clinically important reductions in pain scores and drug side effects by crossing to IDDS. IDDS are shown to be comparable to other high-cost but effective cancer interventions. With refractory pain, the addition of IDDS to CMM can significantly improve pain management. A survival time of three months may be long enough for IDDS implant to be cost-effective.

• Small number of patients
• Question if improvement could be related to patients changing therapy when symptoms worsened, the Hawthorne effect, or placebo effect (implantation of a technological advanced device)
• Results may not be applicable to other centers with less experienced CMM or IDDS.

Studies need to look at the reason for improved survival with better pain control.

Determine the effect of duloxetine on pain severity

Patients were randomized to two study groups: group A subjects received 60 mg of duloxetine initially and then were crossed over to receive placebo and group B subjects initially received placebo and then were crossed over to duloxetine. The initial study period was five weeks. This was followed by a two-week washout period and then a final study period of an additional five weeks. Patients were assessed weekly. Use of other drugs that affect serotonin levels was not allowed. Concomitant use of other analgesics was allowed.

• N = 141
• MEAN AGE = 59 years (SD = 10.5 years)
• MALES = 37%, FEMALES = 63%
• KEY DISEASE CHARACTERISTICS: The majority of patients had gastrointestinal or breast cancer. All had received neurotoxic chemotherapy with taxanes or platinum compounds. 44% were considered high risk for peripheral neuropathic pain due to other conditions such as diabetes. All had at least grade 1 sensory pain on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 3.0) and reported at least level 4 neuropathic pain on a 10-point scale for three or more months after completing chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: 81% were Caucasian; 14% were black.

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: United States

PHASE OF CARE: Transition phase after active treatment

Double-blind, placebo-controlled, crossover, randomized controlled trial

• Breif Pain Inventory (Short Form): Average pain severity was used as outcome.
• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx)
• National Cancer Institute Common Terminology Criteria for Adverse Events (v 3.0)

Among patients who received duloxetine first, 59% reported some decrease in pain, 30% reported no change in pain, and 10% reported increased pain. Compared with placebo, there was a significant chance of receiving a 30% reduction in pain score (RR = 1.96, 95% CI 1.15-3.35) and a 50% reduction in average pain (RR = 2.43, 95% CI 1.11-5.30) with duloxetine. Analysis suggested a greater benefit in patients receiving platinums compared to those who received taxanes. Patients who received duloxetine in the second study period appeared to show greater reduction in average pain scores. Overall duloxetine treatment effect on pain was significant (p < .001). After initial treatment, 41% on duloxetine reported decrease in numbness and tingling in the feet versus 23% on placebo (p ≤ .05). This trend continued through the crossover period. In the duloxetine group, 11% dropped out due to adverse events, compared to 1% receiving placebo. More patients on duloxetine experienced nausea. Other adverse effects were similar between treatments. The most common adverse effects were fatigue and insomnia.

Compared to placebo, duloxetine treatment had a significant effect on pain from chemotherapy-induced peripheral neuropathy. Duloxetine also had some positive effect on numbness and tingling symptoms in the feet but not in upper extremities.

• Measurement validity/reliability was questionable.
• Subject withdrawals were ≥ 10%.
• Concomitant analgesics and changes in analgesics were not described.
• It is unclear why an apparent greater effect on average pain with duloxetine occurred in the second study period for group B. 
• There was an overall 19% drop-out rate.
• A higher proportion of grade 3 toxicities occurred with duloxetine.
• Only average pain, and pain interference during the initial study period, were compared, rather than comparison between the two study conditions. Why this was done is not clear..

Findings show that duloxetine can be effective in reducing pain from chemotherapy-induced peripheral neuropathy. Duloxetine also was associated with more adverse events. Nurses will need to monitor for adverse events, particularly for patients who may already be experiencing sleep wake disturbance and fatigue.

• FINAL NUMBER STUDIES INCLUDED = 13
• TOTAL PATIENTS INCLUDED IN REVIEW = 590
• KEY SAMPLE CHARACTERISTICS: The majority of the studies were of patients with diabetic neuropathy (7 of 13 were exclusively diabetic neuropathy; 8 of 13 were randomized, controlled trials; and 5 of 13 were quasiexperimental).

PHASE OF CARE: Late effects and survivorship

The variety of interventions and outcome measures made the pooling of data in this literature review difficult. Overall, very few randomized, controlled trials exist in this field. The authors described single study results throughout the study but did not pool the results; rather, they placed them in table. Each study was evaluated separately.

Some evidence supports the use of exercise to improve function in those with peripheral neuropathy. Exercise can improve function, balance, and gait for individuals with polyneuropathies and may delay the onset of peripheral neuropathy when administered long-term. For maximum effect, exercises or interval training were to be performed for 2–3 sessions per week with a minimum of 100 minutes of activity. Some of the exercise regimens may not be feasible in patients with cancer because of other side effects of therapy.

Study inclusion was stated but not exclusion. Only 13 studied were evaluated. No pooled data existed—too much heterogeneity. The information may not be useful in oncology because the majority of studies were of patients with diabetes or autoimmune neuropathy.

Nurses should focus further research on exercise in chemotherapy-induced peripheral neuropathy and should educate patients on symptoms and possible interventions for this side effect.

To describe the management of lymphedema in patients treated for head and neck cancer using complete decongestive therapy

This was a retrospective medical record review of patents evaluated and treated for lymphedema with head and neck cancer. Documented results were obtained at baseline and at the first evaluation after complete decongestive therapy (CDT). Patients had at least one training session for self-administration of manual lymph drainage, compression garments, skin care, and exercises for the face, neck,and oral cavity. Patients with severe lymphedema received two to five sessions of CDT with a therapist for two to four weeks as well as a daily self-administered home session, which was continued for as many as three months.

• N = 733  
• MEDIAN AGE = 61 years (range = 21–91 years)
• MALES: 79%, FEMALES: 21%
• KEY DISEASE CHARACTERISTICS: The most common tumor sites were the oropharynx, oral cavity, and larynx. The most common primary surgery prior to referral was total laryngectomy, and 54% of participants received lymph node dissections. The most common sites of edema were the neck and submental regions. Sixty-eight percent of patients had difficulty swallowing, 39% had difficulty breathing, and the majority had cosmetic concerns.

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: Texas

Retrospective, descriptive study

• Clinical evaluation using Foldi's Stages of Lymphedema Scale
• Measurements were summed to create a composite score.

The median time from the baseline assessment to follow-up was 69 days with a range of 9–371 days. Eighty-seven percent of patients reported at least partial adherence to self-administered home management. Overall, 60% of patients showed an improvement in lymphedema. Those who received therapist-administered sessions were more likely to show improvement at follow-up (72%) compared to those who only received the self-administered program (58%, p = 0.014). Those with the worst lymphedema demonstrated the most improvement.

CDT can be beneficial for the treatment of lymphedema in patients with head and neck cancer.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: There was no standard timing for the follow-up assessment and lymphedema measurement. The method of measurement was not sensitive or responsive enough to identify anything other than gross changes.

The measurement of lymphedema associated with head and neck cancer treatment is difficult. CDT has been shown to be effective in the management of lymphedema of the extremities, and this study suggests that it also is helpful for head and neck lymphedema. The differences among those who received therapist-delivered CDT versus those who did self-administered therapy are not clear because of measurement limitations, patient adherence, and other factors.