Smith, T.J., Coyne, P.J., Parker, G.L., Dodson, P., & Ramakrishnan, V. (2010). Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. Journal of Pain and Symptom Management, 40, 883-891.
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.
Prospective study
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.
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.
Smith, M.C., Kemp, J., Hemphill, L., & Vojir, C.P. (2002). Outcomes of therapeutic massage for hospitalized cancer patients. Journal of Nursing Scholarship, 34, 257–262.
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.
Active treatment phase
A quasi-experimental design was used.
Provision of therapeutic massage in hospitalized patients with cancer may have a positive effect on pain and symptom distress.
This study did not provide any strong support for the use of therapeutic massage in hospitalized patients with cancer.
Smith, M. C., Kemp, J., Hemphill, L. & Vojir, C. P. (2002). Outcomes of therapeutic massage for hospitalized cancer patients. Journal of Nursing Scholarship 34, 257–262.
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.
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.
Smith, T.J., & Coyne, P.J. (2005). Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain patients. Journal of Palliative Medicine, 8, 736–742.
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.
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.
Studies need to look at the reason for improved survival with better pain control.
Smith, E.M., Pang, H., Cirrincione, C., Fleishman, S., Paskett, E.D., Ahles, T., . . . Alliance for Clinical Trials in Oncology. (2013). Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: A randomized clinical trial. JAMA: The Journal of the American Medical Association, 309, 1359-1367.
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.
PHASE OF CARE: Transition phase after active treatment
Double-blind, placebo-controlled, crossover, randomized controlled trial
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.
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.
Smith, M.B., & Mulligan, N. (2014). Peripheral neuropathies and exercise. Topics in Geriatric Rehabilitation, 30, 131–147.
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.
Smith, B.G., Hutcheson, K.A., Little, L.G., Skoracki, R.J., Rosenthal, D.I., Lai, S.Y., & Lewin, J.S. (2015). Lymphedema outcomes in patients with head and neck cancer. Otolaryngology: Head and Neck Surgery, 152, 284–291.
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.
Retrospective, descriptive study
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.
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.
Smith, C.A., Pirotta, M., & Kilbreath, S. (2014). A feasibility study to examine the role of acupuncture to reduce symptoms of lymphoedema after breast cancer: A randomised controlled trial. Acupuncture in Medicine. Advance online publication.
To determine the feasibility, acceptability, and safety of acupuncture to treat arm lymphedema in women following treatment for breast cancer
This was a randomized, controlled trial of acupuncture compared to usual treatment. Twenty women with stable, unilateral, intransient lymphedema that was present for at least six months prior were recruited. Ten participants were in the control group. The remaining 10 received 12 acupuncture treatments administered to body and arm points on the nonlymphedematous limb over eight weeks, twice weekly for four weeks then once weekly for four weeks. Clinical outcomes were assessed at baseline and again after eight weeks.
Randomized, controlled trial
Compliance with the treatment protocol was high; 37 women were recruited and 20 were included in the trial. Three women withdrew from the trial. Participants reported an average of two symptoms associated with treatment. Acupuncture did not worsen lymphedema in the intervention group. The change in BIS measurements ranged from a 0.01 increase to a 0.3 decrease in the control group. The intervention group’s BIS measurements saw an increase of 0.28 and a decrease or 0.43. No increases in swelling greater than 10% occurred. No changes in quality of life or other patient-reported outcome measures related to lymphedema were reported.
Acupuncture did not cause any significant changes in limb volume for women with arm lymphedema. It may stabilize lymphedema symptoms. No major safety concerns were identified.
Acupuncture did not improve or exacerbate lymphedema in women who were breast cancer survivors. At this time, there is not enough research to promote the use of acupuncture as an effective intervention for the reduction of arm volume in this population.
Smith, T.J., Bohlke, K., Lyman, G.H., Carson, K.R., Crawford, J., Cross, S.J., . . . American Society of Clinical Oncology. (2015). Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. Journal of Clinical Oncology, 33, 3199–3212.
RESOURCE TYPE: Evidence-based guideline
PHASE OF CARE: Active antitumor treatment
Sixty-six publications formed the evidence base for the recommendations. Forty-one were randomized, controlled trials.
The guidelines provide general recommendations for the primary and secondary prophylactic use of CSFs in patients being treated for cancer, and also outlines concerns regarding cost and the potential overuse of CSFs. The determination of a 20% risk for febrile neutropenia was not straightforward given patient variation and regimen alterations according to individual patient responses. Further work is needed to develop and evaluate clear individualized risk-based models for CSF use in a variety of patients with cancer.
Smith, C., Carmady, B., Thornton, C., Perz, J., & Ussher, J. M. (2013). The effect of acupuncture on post-cancer fatigue and well-being for women recovering from breast cancer: a pilot randomised controlled trial. Acupuncture in Medicine, 31, 9–15.
To evaluate the feasibility and acceptability of acupuncture in managing fatigue and well-being in women with breast cancer.
Patients were randomized to acupuncture, sham control, or wait-list control groups. Six acupuncturists provided the interventions. All needles were inserted with a Park device for both the sham and actual groups. Treatments were performed twice weekly for three weeks and then weekly for another three weeks. Acupuncture was administered at five points, and the needles were stimulated manually. Needles were retained for a maximum of 20 minutes, and sessions lasted 45 minutes. Women in the wait-list control were contacted every four days during the study. Women in the acupuncture group were also interviewed to explore the perceived impact of the intervention.
The study used a randomized, sham-controlled trial, with a mixed method.
Fatigue declined over time in all three groups. It was reported that fatigue declined significantly in the acupuncture group after two weeks; however, no statistical results were provided. Almost half of the women recruited declined participation, mainly due to the travel distance required. Well-being scores improved in all women, with no differences between groups. Findings from interviews showed that women who received acupuncture experienced improved sleep and relaxation with treatments and improved mood.
Findings suggested that acupuncture treatment is feasible in this group of patients and may be of benefit in improving fatigue.
The study had a small sample size, with less than 100 patients.
The study suggested that acupuncture was feasible as provided and might have benefit in the management of fatigue; however, the study did not provide strong evidence to support the efficacy of acupuncture to improve fatigue.