The purpose of the study was to evaluate the effect of gabapentin on chemotherapy-induced peripheral neuropathy (CIPN).

Patients were assigned to either one of two groups: gabapentin followed by placebo or placebo followed by gabapentin. Doses of both capsules were incrementally increased during the course of three weeks to a target does of 2,700 mg. Patients were treated for six weeks and then had a two-week washout period. After the washout period, patients were treated for another six weeks in the crossover. The sample size was determined by power analysis and study measures were obtained weekly.

• The sample consisting of 68 participants with a mean age of 59 years and a range of 25–84 years.
• Women outnumbered men, 73%–27%, respectively.
• Specific diagnoses were not described by the authors, but 50% of the participants were on active treatment at the time of the study.
• All patients had symptom severity of 4 or greater on a numerical rating scale for peripheral neuropathic pain.
• Patients were receiving vinca alkaloids, taxanes, cisplatin-based compounds, or some combination of these.

The study was conducted at multiple outpatient settings in the north-central region of the United States.

• A numeric rating scale of 0-10 for pain.
• The World Health Organization classification scale for neuropathic symptoms (parasthesias, tendon reflexes, weakness, motor loss included).
• The short form McGill pain questionnaire.
• The Brief Pain Inventory.
• A symptom distress scale (five point).
• The Profiles of Mood States.

The McGill pain rating questionnaire at six weeks indicated lower pain in the gabapentin-treated groups. No other differences were noted between groups at any point in time during the study. On the numerical scale, a slight reduction in pain was seen in all participants. Improvement was highest in patients who had higher baseline average pain and in those currently in active chemotherapy treatment.  Most frequent adverse events were dizziness and fatigue and no differences in adverse events were noted based on gabapentin treatment.

The findings failed to demonstrate any benefit in using gabapentin for CIPN.

• Limitations included a sample size of less than 100 participants.
• A 41% dropout rate occurred, which was not discussed.
• Because of the dropouts, the sample size in the final analysis was underpowered.
• No intention-to-treat analysis was reported and no mention was made of other medications used to treat pain.

The findings do not support the use of gabapentin for the management of CINV.

To compare effects of a 24-week yoga program with those of a supportive therapy control intervention in patients with early breast cancer

Prior to surgery, patients were assessed and randomly assigned to the yoga program intervention or control condition. All patients received 50 cGy of radiation therapy over six weeks and were prescribed six cycles of standard chemotherapy with the same schedule. Patients in both groups received alpraxolam 0.5 mg once daily for one week following chemotherapy for the first one to two chemotherapy cycles. Patients in the yoga group had four in-person sessions during the perioperative period and were to undergo three in-person sessions per week for six weeks during radiotherapy treatment, with self-practice on the remaining days. During chemotherapy, patients had in-person sessions during visits (one per 21 days) and in-person sessions with a trainer every 10 days. The instructor monitored self-practice through telephone calls and house visits. The control intervention was brief supportive therapy with education, including 15-minute counseling sessions every 10 days during treatment by a social worker. All patients were asked to maintain daily diaries of symptoms, medication, and diet intake, and for those in the yoga group, their frequency and duration of yoga practice.

• The study reported on a sample of 38 female patients.
• Age information was not reported.
• All patients had early-stage breast cancer, and 51% were postmenopausal.
• Of the total sample, 28% reported having other stressful life events in the past two years.

• Single site
• Inpatient and outpatient setting
• India

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• State-Trait Anxiety Inventory: symptom grading on 0–4 Likert-type scale
• Patient diary

Sixty-one percent of patients initially randomized dropped out of the study. Approximately half of these patients decided to leave the study after initial surgery, and the rest of the dropouts were removed from the study because they did not end up receiving the same expected adjuvant treatment sequence. Anxiety declined over time in all patients, and overall ANOVA did not show a significant group and time effect. Post hoc analysis showed that the yoga group had significantly lower anxiety immediately postsurgery and midway through radiation therapy (p < 0.05) and midway through chemotherapy (p < 0.001). Analysis of overall symptom distress showed a significant effect of the yoga group over time for reduction in symptom distress (p = 0.001). Post hoc testing showed a significant decrease in trait anxiety in the yoga group compared to controls at several time points in the study (p < 0.01). The effect size for state anxiety was 0.33. Anxiety and symptom distress were strongly correlated at all phases of treatment, with r ranging from 0.49 to 0.73 (p < 0.05).

Anxiety decreased over time in all patients. The yoga intervention was associated with a significantly greater reduction in anxiety at several time points in the treatment schedule, immediately following surgery, midway through radiation therapy, and midway through chemotherapy.

• The study had a small sample size, with less than 100 participants. Although small, the sample size was based on power analysis, but assumed a larger anxiety effect size than found in this study.
• The study had a very high drop-out rate. Intention to treat analysis was done using baseline measures for dropouts, resulting in much less change in outcomes seen, which was not particularly helpful in attempting to evaluate the effects of participation in the intervention. The control condition did provide some patient attention, but it was much less than that received by the intervention group.
• The study did not include information regarding actual patient adherence to self-directed yoga practice.
• Potential risk of bias exists due to no blinding.

Yoga as provided in this study, with individual instructor-directed sessions and patient self-guided practice expectations, had a mild effect in reducing anxiety over time during various phases of cancer treatment. Guided sessions were done at scheduled visits for treatment, suggesting that this can be a practical way to facilitate patient participation. Patients may find yoga helpful to reduce stress and anxiety.

Patients were randomized to either lamotrigine or placebo. Sixty-three patients were randomized to lamotrigine and 62 to placebo. The dose was escalated from 25 mg at bedtime to 150 mg twice daily, a regimen that continued for two weeks. Ten weeks after drug initiation, patients tapered off lamotrigine or placebo over a four-week period.

• The study had a total sample size of 125 patients.
• Patients were treated with neurotoxic chemotherapy.
• Patients were symptomatic for chemotherapy-induced peripheral neuropathy for one month or more, with a daily average pain score of 4 or greater on a 10-point scale or greater than 1 on the Eastern Cooperative Oncology Group Grading Scale for CIPN.

Phase III randomized, double-blind, placebo-controlled trial

• Investigators conducted assessments weekly. A numeric rating scale measured average daily pain scores.
• Secondary measures included the World Health Organization Classification Scale, which rated neuropathy symptoms from 0 (none) to 4 (paralysis).
• The Short-Form McGill Pain questionnaire assessed characteristics of pain (throbbing, stabbing, etc.).
• The Brief Pain Inventory (Short Form) assessed the effect of pain on functional ability.
• The Subjective Global Assessment measured change in overall symptoms from no change to much worse.
• The Symptom Distress Scale, a five-point scale, measured common cancer-related symptoms.
• The Profile of Mood States Short Form, a 30-item scale, measured mood states.
• A single-item tool with a scale 0–100 measured quality of life.
• The Eastern Cooperative Oncology Group Grading Scale for CIPN, a 10-point scale, measured specific pain qualities.
• Investigators used National Cancer Institute common toxicity criteria to grade toxicity.

A total of 125 patients enrolled, but only 80 completed the study. Authors observed no significant differences between the two groups in the pain scale or the ENS.

Lamotrigine was not effective in relieving chemotherapy-induced peripheral neuropathy.

• The sample was mixed, including different levels of chemotherapy-induced peripheral neuropathy, cancer treatments received, cancer diagnoses, and length of time since treatment completion.
• Many primary and secondary outcomes were tested.
• Authors did not account for the use of an error rate of only 2.5% or for stratification procedures by type of neurotoxic regimen. Sampling estimations increased the chance of statistical error.

To evaluate the efficacy of turmeric in preventing radiation-induced mucositis. Secondary endpoints included the efficacy of turmeric rinses on treatment breaks and weight loss.

The trial held the same recommended oral care for the treatment and comparison groups. Participants also were asked to swish after oral intake and wait 30 minutes to eat after swishing with the prescribed solution. The treatment group (turmeric rinses) was instructed to have a caregiver dissolve the contents of one 400 mg capsule of turmeric in 80 ml of boiled and cooled water. The patient was then instructed to swish 10 ml of the solution one hour prior to radiation; one, two, four, and six hours after radiation; and at HS. The comparison group was instructed to mix a povidone-iodine solution at 1 ml Betadine^® to 100 ml water and swish 10 ml twice per day for six weeks.

• N = 80   
• AGE: Older than or equal to 18 years
• MEAN AGE: Treatment group: 56.8 years, comparison group: 55.08 years
• MALES: 80%, FEMALES: 20%
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer undergoing 70 Gy radiation or radiation plus chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: No oral surgery six weeks prior to study; no previous treatment to head or neck; no high doses of non-steroidal anti-inflammatory drugs; no poorly controlled DM; no hypertension, schizophrenia, bipolar disease, or severe depression

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Mangalore Institute of Oncology, Mangalore, India

• PHASE OF CARE: Active antitumor treatment

• Single-center, investigator-blinded, randomized controlled trial

• Radiation Therapy Oncology Group oral mucositis grading system

There was a significantly (p < 0.0001) lower rate of intolerable mucositis (grades 3 and 4) in the turmeric group. There was no significant change in treatment days lost between groups. Weight loss in the turmeric group was less (p < 0.001).

Turmeric rinses are beneficial in reducing grade 3 and 4 mucositis in patients with head and neck cancer undergoing chemotherapy or chemotherapy and carboplatin, compared with twice-daily povidone-iodine rinses.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable
• Other limitations/explanation: Comparison of povidone-iodine twice-daily rinses might not be a fair comparison, as there is not good evidence thus far that povidone-iodine rinses are a good treatment for preventing oral mucositis. Additionally, the patients clearly were not blinded. Lastly, twice-a-day rinsing versus six-times-a-day rinsing does not seem to be an appropriate comparison.

Turmeric rinses may provide some protection against oral mucositis for patients with head and neck cancer undergoing radiation and radiation plus chemotherapy; however, more research is needed. The treatment was reported as well tolerated, and there was no mention of adverse side effects.

To evaluate the effects of a yoga program versus supportive care on symptoms of depression among women with breast cancer during treatment

Patients were randomized to the yoga program or a control supportive therapy program. Yoga included education, breathing exercises, meditation, and relaxation techniques with imagery. Subjects were provided with audiotapes of the practices for use at home. Home practice was monitored via telephone calls, weekly home visits, and a daily patient log. Subjects were to practice at home for at least one hour three times per week. The comparison group used supportive, expressive therapy and education provided by therapists in an unstructured approach aimed at addressing fears and concerns and improving support from others among other issues. The intervention took place over a 24-week period including the time of surgery and following adjuvant chemotherapy or radiotherapy. There were four to six study assessments, depending on the treatment, that were scheduled pre- and postsurgery and mid- and postradiation or chemotherapy. Interventions were done on an individual basis.

• N = 69
• AGE: Not provided
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 87% of participants had grade 3 breast cancer.

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

• PHASE OF CARE: Active antitumor treatment

Single, blinded, randomized, controlled trial

• Beck Depression Inventory (BDI)
• Symptom checklist

Both groups reported decreased depression over time. An analysis of covariance showed a larger decrease in depression at all time points measured in the yoga group (p < 0.01). The study sample was appropriate according to the authors' power analysis. Depression scores were directly and strongly correlated (ranged from 0.49–0.77, p < 0.001) with symptom distress scores.

Yoga was shown to be beneficial in reducing symptoms of depression among women with breast cancer during the trajectory of active treatment. Depression was strongly related to symptom scores.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: There was an initial drop-out rate of about 30% that was fairly evenly spread across both study groups. Patients were not blinded. This study had a repeated measures design with a potential testing effect. There was no information regarding the patients' actual adherence to the prescribed frequency of yoga practice. Control patients had only one session in the perioperative phase and one follow-up session compared to the weekly visits for the intervention group. Baseline depression scores were higher in the control group. No information was provided regarding symptom management.

The findings of this study suggest that yoga is beneficial to women with breast cancer during active treatment to manage depressive symptoms. They also show that adverse symptoms were strongly related to depression, and depression was higher with more severe adverse symptoms. This points to the importance of effective symptom management as part of the overall reduction of depression.

To evaluate the effectiveness of complete decongestive therapy (CDT) in Indian patients

Patients had clinical evidence of lymphedema (with a difference in arm volumes of at least 200 ml) and were being treated with CDT. They also were at least four months since surgery or radiation therapy. CDT consisted of intensive therapy using manual lymph drainage for 45 minutes four times a week followed by multilayer compression bandaging. Patients were educated on skin and nail care, use of isotonic exercises with bandages on, and re-application of bandages. After the intensive phase, patients were to massage themselves twice daily, perform isotonic limb exercises, and care for skin and nails three times a day. They also applied low-stretch compression bandages and elevated the limb at night. Assessments were performed before and after the intensive phase and monthly for three months.

• Mean age of the sample (N = 32) was 52 with a range of 30–76.
• All patients were females who had surgery for breast cancer with level II axillary dissection.
• Patients with recurrent disease were excluded.
• Twenty-four percent of patients had puckered scars, indicative of severe infection or radiodermatitis. 
• Ninety-two percent had adjuvant chemotherapy and post-operative radiotherapy. 
• Most patients had lymphedema of the right arm and were right handed

• Single site
• Outpatient
• India

The phase of care was the transition phase after active treatment.

 The study used a prospective trial design.

• Water displacement was used to measure volume.
• Circumferential arm measurements were taken.
• Skin and subcutaneous thickness was measured using high-frequency ultrasound probes.
   

After intensive therapy, the mean reduction in absolute limb volume was 485 ml by volumetry and 2,274 ml by measurement (p < 0.001).  In the maintenance phase, there was a non-significant increase in limb volume of 20.3 ml.  Reductions in skin and subcutaneous thickness showed the same pattern as the volume reduction. Three patients developed skin irritation and blistering following bandage application, and one patient who developed recurrent cellulitis following bandaging in the maintenance phase was excluded from the study.

The study demonstrates effectiveness of intensive CDT for management of lymphedema.

• The study had a small sample size (N < 100).
• There was no control group, binding, random assignment, or appropriate attention control condition.
• Subjects who developed skin problems with bandaging were removed from the study with no intent-to-treat analysis.
• Information about degree of adherence to maintenance therapy is not provided.
• The follow-up period for maintenance evaluation was relatively short. 

Findings demonstrated effectiveness of intensive CDT for lymphedema management and effectiveness of maintenance therapy for several months. Findings also showed the need for patients and caregivers to closely monitor skin condition with use of compression bandaging as well as have knowledge of related self care. It appears that self massage and bandaging can be used effectively for maintenance. It is important for patients to know how to perform self care and mointor side effects and be able to adhere to self-care regimens. 

PHASE OF CARE: Transition phase after active treatment
 
APPLICATIONS: Elder care, palliative care

Venlafaxine is superior compared to placebo or other nonhormonal therapies in the management of hot flashes. Clonidine also demonstrated benefits.

Dose of 75 mg venlafaxine is efficacious for hot flashes in women with breast cancer and should be considered as a first-line treatment. Venlafaxine or clonidine is safe and not associated with breast cancer mortality or CYP2D6 activity.

There was a high heterogeneity among trials. None was analyzed as intention to treat (ITT) analysis. Concealment of allocation was unclear among three of six. Blinding was not feasible in the study with acupuncture. In five of six studies, blinding of outcome assessment was unclear or absent. Incomplete data or missing was not equal in groups in all studies.

This is important for cancer survivors without clear guidelines on symptom management after cancer treatment. North American population, mostly tool validation; expected differences in other populations. An apparent benefit exists in reducing hot flashes, but it needs a multicentered trial to confirm. Nurses should advise further research in standardizing hot flash scoring and need a standardized scoring approach.

Authors recruited for the study were patients with stable metastatic breast cancer or prostate cancer who had at least a six-month life expectancy. Patients were randomized into an immediate treatment group and a wait-list control. All participants had follow-up at 6, 12, and 18 weeks. The intervention consisted of keeping a well-being diary, using a CD with a 10-minute recording to complete a mindfulness body scan, and planning a pleasurable activity.

• The sample was composed of 27 participants with metastatic breast or prostate cancer.
• Mean age of women was 60.8 years; mean age of men was 72.4 years.
• Of female participants, 13 were in the analysis phase; of males, 14 were in the analysis phase.
• A stable life expectancy greater than 6 months was a condition of inclusion. Patients with a psychiatric diagnosis were included if the condition was diagnosed as stable.

• Single site
• Outpatient
• Cambridge, Cambridgeshire, England

Active treatment and transition

Randomized controlled trial

• World Health Organization Quality of Life Instrument-BREF (WHOQOL-BREF)
• Hospital Anxiety and Depression Scale (HADS)
• Social and Occupational Functioning Assessment Scale (SOFAS)
• Life Orientation Test, Revised (LOT-R)
• Ten Item Personality Inventory (TIPI)

Positive qualitative feedback reflected a statistically significant (p = 0.046) improvement in quality of life. Although HADS scores improved after the intervention, the change was not significant, and SOFAS scores did not change significantly. Adherence to the intervention was 67% for CD listening, 71% for writing in the diary, and 46% for activity planning.

The intervention was associated with some improvement in quality-of life-measures, but there was no effect on depression or anxiety.

• The study had a small sample size, with fewer than 30 participants and a high attrition rate.
• The study had risk of bias due to no blinding.
• Measures of internal consistency reliability for the instruments were not reported.
• Follow-up occurred by different methods: in the clinic, at home, via telephone, or by means of a mailed survey.
• Patients complained of repetitiveness in the diary-writing aspect of the intervention. They study did not include analysis of patient adherence to or actual use of the approach.

Findings do not indicate that mindfulness-based intervention, as used in this study, had an impact on well-being.

To test the feasibility of a brief self-administered psychological intervention to improve well-being in patients with cancer

The intervention consisted of patient diary and CD meditation for home use with brief telephone support. Patients were requested to record three positive experiences each day in the diary and to plan one enjoyable activity each week and record in the diary. A recorded mindfulness “body scan” (meditation approach) 10 minutes in length was provided to each patient, and he or she was instructed to use this twice a day. Brief telephone contact was made in weeks 1, 2, and 4 to answer questions and encourage continued home practice.

• The study reported on a sample of 46 patients.
• Mean patient age was 60.8 years for women and 72.4 years for men.
• The sample was 47.8% female and 52.2% male.
• Female patients were diagnosed with breast cancer, and male patients were diagnosed with prostate cancer.

• Outpatient setting
• United Kingdom

Patients were undergoing the transition phase of care after initial treatment.

A randomized controlled trial design was used.

• World Health Organization Quality of Life Scale (WHO-QOL-BREF)
• Hospital Anxiety and Depression Scale (HADS)
• Social and Occupational Functional Assessment Scale (SOFAS): Interviewer-rated measure of overall level of functioning
• Life Orientation Test–revised (LOTR): 10-item scale to measure optimism/pessimism
• Ten-Item Personality Inventory (TIPI)

The drop-out rate was almost 50% at the six-week point. Quality of life showed significant improvement at the six-week point (p = 0.046). No other significant differences were identified.

Compliance rates of patients remaining in the study suggest that the approaches used here were easy enough to use and acceptable to them; however, the extremely high drop-out rate suggests that the actual feasibility of this approach for any length of time is questionable.

• The study had a small sample size.
• The study has questionable feasibility due to the high drop-out rate.
• The final sample was too small to detect any significant differences.

This study involved multiple follow-up periods and several self-report questionnaires. The burden of this activity may have contributed to the high drop-out rate.

Determine the effectiveness of group psycho-education on well-being and depression among breast cancer survivors in Malaysia

In this cluster, non-randomized trial conducted over a one-month period, 34 adult women with non-metastatic breast cancer participated in a group psycho-education class on well-being status and depression. The class was designed to inform and discuss cancer and treatment. They were evaluated with a pre/post-test questionnaire, as well as a pretest socio-demographic questionnaire.

• N = 34    
• AGE = Older than 18 years; 47% older than 50 years; 26.5% for both 30–49 years and younger than 30 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Non-metastatic breast cancer on appropriate medications
• OTHER KEY SAMPLE CHARACTERISTICS: 70.6% were married; 47% completed secondary level of education, 32.3% completed primary level of education, and 20.6% completed college level of education; 29.4% were employed; comorbid conditions: 55.6% had hypertension, 44.4% had diabetes, and 22.2% had both

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Melaka, Malaysia

PHASE OF CARE: Active antitumor treatment

Cluster, non-randomized trial

• Pre-test questionnaire for socio-demographic profile
• World Health Organization (Five) Well-being Index (WHO-5 Well-being Index)

The study showed that psycho-education decreased depression and increased the state of well-being among participants. Post-test results significantly improved for three of the five items on the WHO-5 Well-being Index.

Psycho-education may be one way to improve the overall well-being of patients diagnosed with breast cancer. More research is needed with larger numbers and a multi-site setting to validate improved well-being.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias(sample characteristics)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Only women included; findings not generalizable because of small size
• Measurement of well-being not clearly reflective of anxiety or depression

Psycho-education may be one way to improve the overall well-being of patients diagnosed with breast cancer, but as nursing professionals, taking a holistic approach to patient care and recognizing and addressing other contributing factors, such as biological and social factors, are important.