The purpose of the study was to evaluate the effects of gabapentin with nonsteroidal anti-inflammatory drugs (NSAIDs) and morphine versus gabapentin alone.

Participants were randomized into three groups. Group 1, consisting of 25 participants, received gabapentin alone, titrated weekly from 300 mg per day to 3,600 mg per day in divided doses. Group 2, consisting of 25 participants, received gabapentin 1,200 mg per day and diclofen 100 mg per day, also titrated over the first week. Group 3, consisting of 25 participants, received gabapentin 900 mg per day, diclofen 100 mg per day, and morphine 60 mg per day all in divided doses. Patients were treated for six weeks and assessed on a weekly basis.

• Seventy-five participants, all women aged 23–74 years (with a median age of 44 years), took part in the study.
• Participants were patients with breast cancer who were previously treated with any combination of chemotherapy, radiation therapy, and surgery, with neuropathic pain occurring post-treatment.
• Additional eligibility requirements included participants having a pain intensity rating of 5 or higher on a visual analog scale, having pain duration of at least three months, being older than age 18, being cognitively intact, having normal renal function, and having no gastrointestinal issues.

This single-site study was conducted in an outpatient setting in Serbia.

Phase of care

• Transition
• Long-term follow-up

Applications

• Late effects
• Survivorship

This study was quasiexperimental.

• Measurement tools included a visual analog scale, a modified Brief Pain Inventory, and the Pain Intensity Difference scale.
• Side effects from the medications used were assessed using a four-point Likert-type scale (0–3), with 0 indicating no side effects and 3 indicating severe side effects.

Participants in all three groups saw diminished pain and diminished influence of pain on their daily activities. No significant difference was noted between groups (p = 0.05).

Although all groups achieved significant pain control, the authors concluded that the multimodal therapy used in group 3 provided the best pain relief with the fewest side effects. However, inconsistency existed regarding doses between groups and, although differences in pain levels in each group diminished over time, between-group differences were not significant. No firm conclusions can be made.

• Limitations include a lack of control group, the potential for bias with no blinding method enacted, and that no valid measure of neuropathy was used.
• Actual dosages used varied from group to group, so clear conclusions are difficult.

The results support a multimodal approach to pain management in patients with breast cancer with neuropathic pain, but are not specific to peripheral neuropathy. The findings do not suggest any difference between the treatments tested in terms of efficacy; however, multiple limitations did exist in the study.

To evaluate the effects of multimodal therapy on intensity and relief of treatment-related neuropathic pain in patients with breast cancer

This study consisted of 75 patients with breast cancer who were experiencing neuropathic pain randomly divided into three groups. Group 1 received gabapentin only, starting at 300 mg, titrated up to 3,600 mg/day until an adequate response was obtained. Group 2 received a constant dose of 1,200 mg gabapentin and 100 mg diclofen gradually titrated up. Group 3 received multimodal therapy including 900 mg gabapentin, 100 mg diclofen, and 60 mg M-Eslon. Additional medicine was allowed PRN.

• The study reported on 75 patients with breast cancer experiencing neuropathic pain.
• Median patient age was 44 years.
• Patient gender was not specified directly, but was assumed to be 100% female due to breast cancer population.
• Patients underwent different treatments and therapies for breast cancer.
• At study entry, all patients had pain intensity of at least 5 on a visual analog scale (VAS), and pain duration of at least three months.

• Single site
• Serbia

• Patients were undergoing the transition phase of care after initial treatment.
• The study has clinical applicability for late effects and survivorship.

A randomized, three-group, parallel study design was used.

Modified Brief Pain Inventory questionnaire (VAS/Likert scale)

Group 3 (which received the combination of three medications) achieved the highest level of pain relief; however, there was no significant difference between groups. There was a statistically significant drop in pain intensity for all groups. The largest decrease was achieved at time of the first visit. Side effects increased in intensity over time, and group 2 experienced the most intense side effects.

Multimodal therapy seems to have some benefit on neuropathic pain in patients with breast cancer.

• The study did not include an appropriate control group.
• The study had a small sample, with less than 100 patients.
• The study lacked blinding, and confounding variables were present. Patients were to receive morphine as needed for breakthrough pain; however, breakthrough episodes and opioids used were not evaluated.

Patients with breast cancer would appear to benefit from multimodal therapy including different drugs and dosages to treat their neuropathic pain. Nurses should watch for an increase in side effects at subsequent follow-up visits.

To determine if quetiapine, an atypical antipsychotic, would improve insomnia in patients with breast cancer being treated with tamoxifen (tamoxifen-related insomnia).

Quetiapine was initiated at 25 mg/day, given one hour before bedtime. Dosages were titrated up to 100 mg/day based on patient tolerance and response to medication. Patients were assessed using tools for depression and insomnia at baseline and weeks 1 and 6 weeks into therapy.

• The sample was comprised of six women.
• Age ranged from 38 to 52 years.
• Patients were women with localized breast cancer (stage II–III-A) receiving tamoxifen (20 mg) 3 to 12 months after definitive primary therapy, including adjuvant chemotherapy and radiotherapy.
• Four of six patients were married.
• Patients had taken no psychotropic medications in the preceding month.

• Single site  
• Italy

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

This was a single-group, repeated measure, case study.

• Structured Clinical Interview for DSM-IV (SCID-I)
• Beck Depression Inventory (BDI)
• Hamilton Rating for Depression (HAM-D)
• Insomnia Severity Index (ISI), Italian version

Five of six patients had rapid (at one week) improvement in insomnia based on ISI scores. This effect maintained improvement at six weeks.

Quetiapine may be a useful agent in treating tamoxifen-related or tamoxifen-induced insomnia in women with breast cancer.

• This was a case study or case report only.
• The study had a small sample size.
• No statistical analysis was performed.
• The study lacked biobehavioral assessments and objective sleep measures.
• Dosages of quetiapine were variable.

Quetiapine, an atypical antipsychotic, may be a potential option for treating tamoxifen-related insomnia without depression. A larger study is required.

To retrospectively examine how axillary reverse lymphatic mapping (ARM) affects patients perceived incidence of lymphedema compared to patients who did not receive ARM

A retrospective review of 46 patients with breast cancer who had greater than 10 lymph nodes removed were recruited and surveyed to determine which patients identified as having lymphedema and whether they required treatment or therapy for it. Patients were also asked if they underwent the ARM procedure.

• N = 46   
• MEAN AGE = 57 years  
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer with axillary node dissection

• SITE: Retrospective (not applicable)
• SETTING TYPE: Retrospective (not applicable)
• LOCATION: Portland, Oregon

• PHASE OF CARE: Late effects and survivorship 
• APPLICATIONS: Palliative care 

• Retrospective review

A survey was created and sent to all women who qualified for the study from the Community Hospital Tumor Registry in Portland, Oregon.

Twenty-two patients reported undergoing the ARM procedure compared to 24 patients who did not undergo the ARM procedure. Of the 22 who did, 39% reported having lymphedema compared with 50% of the non-ARM patients. Eighteen percent of the ARM group reported requiring a compression sleeve for treatment of lymphedema compared to 45.8% of women in the non-ARM group.

The incidence of patient perceptions of lymphedema and the use of compression sleeves were lower in the ARM group than in the non-ARM group.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Selective outcomes reporting
• Measurement/methods not well described
• Measurement validity/reliability questionable 
• Findings not generalizable
• Fifty-seven percent of patients contacted for the retrospective study did not complete the survey.

The effect of using the ARM procedure to decrease lymphedema cannot be ascertained from this study.

The Family Caregiver Cancer Education Program consisted of three group sessions in two-hour blocks as a psychoeducational program for caregivers led by nurse–social worker teams. A panel of 20 multidisciplinary experts in oncology designed the program content.

Topic areas in the program included

• Talking to a loved one’s physician and managing in the healthcare system
• Handling role and family relationship changes
• Care of medical equipment
• Managing symptoms
• Talking to children
• Managing other jobs and responsibilities
• Handling insurance and financial issues
• Dealing with emotional reactions
• Finding and asking for help
• Self-care maintenance.

• The sample (N = 187) included English- or Spanish-speaking caregivers who attended the program and completed baseline and four-month follow-up measures.
• Caregivers provided care to patients with a variety of cancer diagnoses during or after transition points of illness.

Caregivers of patients with cancer from 18 healthcare agencies in a large northeastern city (results from one site of a larger multisite study)

A nonrandomized, well-designed trial design was used, with pretest, post-test, baseline, and four-month postintervention scores completed.

• Caregiver Reaction Assessment
• Caregiver Demands Scale

• Only the impact of caregiving on household finances (dimension of burden) showed significant improvement from baseline to four months postintervention.
• Significant improvement was found in knowledge and assessment of the caregiver role at four months postintervention.
• A significant gender difference existed: More men withdrew and did not complete the second interview. However, no statistical differences in measured burden were found by gender.

• Selection and self-selection bias is a potential limitation in the study.
• Generalizing is difficult because the burden of caregivers who were unable to attend the program may differ from those who did.

Manual search and MEDLINE, CINAHL, and PsycInfo database searches using the search terms caregiver, caregiving, family, cancer, outcomes, interventions, quality of life, coping, and psychological distress were used.

Twenty-nine articles that described interventions aimed at assisting caregivers of patients with cancer were reviewed. Quality of life, knowledge about pain, caregiver burden, depression, psychological adjustment or functioning, and anxiety were not clearly defined in many of the studies.

Psychosocial status and aspects of caregiver quality of life improved, although improvement in burden not was not described. The effectiveness of interventions to reduce caregiver burden or strain was not established.

• The review was not limited to studies that associated interventions with outcomes and did not critique individual studies.
• Interventions often were not clearly described, and well-delineated outcome variables were lacking.
• Small sample sizes and attrition were problems.
• Randomized trials were lacking.
• Most studies revealed selection bias, often to well-adjusted caregivers.

To review published literature concerning the use of compression treatments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty

The authors searched medical literature databases and reviewed their own collections of papers, monographs, and books for papers providing information about the effects of compression and randomized clinical trials of compression devices. Studies were included in the review if they used compression stockings, bandages, and intermittent pneumatic compression devices. Exclusion criteria were not specified.

The International Compression Club (ICC) reviewed and to commented critically on published literature on compression therapy concentrating on two issues: (a) experimental findings concerning clinically relevant effects of compression therapy and (b) randomized clinical trials (RCTs) addressing the use of compression for particular clinical indications. The findings were presented by several members of the group and discussed at a meeting of the ICC, held in May 2007 in Vienna, Austria. The assessment of the strength of the recommendations from randomized trials was based on the scoring criteria from the international Grading of Recommendations Assessment, Development, and Evaluation (GRADE) group. Thereafter, the data were summarized in tables that were circulated among the members of the ICC by email. The corrected version of these tables was agreed upon by a majority of the active participants at a follow-up ICC meeting, held in November 2007 in Paris.

The number of studies included in the report, total sample size, sample range across studies, and sample characteristics were not mentioned.

A wide range of compression levels was reported to be effective. Low levels of compression 10–30 mm Hg applied by stockings are effective in the management of telangiectases after sclerotherapy, varicose veins in pregnancy, the prevention of edema, and deep vein thrombosis (DVT). High levels of compression produced by bandaging and strong compression stockings (30–40 mmHg) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema. In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment. These included management of varicose veins to prevent progression following surgical treatment or sclerotherapy for varicose veins and the level of compression required to treat acute DVT.

The review shows that while good evidence for the use of compression is available in some clinical indications, there is much still to be discovered. Little is known about dosimetry in compression or for how long and at what level compression should be applied. The differing effects of elastic and short-stretch compression are also little understood.

The study tested whether magnesium would diminish bothersome hot flashes in breast cancer patients

Patients were assessed at baseline for all variables. They recieved magnesium 400 mg daily for 2 weeks. If symptom relief on hot flashes was seen, they stayed with same dose for 2 weeks more. If not, they increased  to 400 mg twice daily for 2 weeks.

Twenty-nine women with a mean age of 53.5 years were enrolled.  All were breast cancer patients with ECOG Performance status 0-1 & 2.  Patients were excluded if they:

• Had decreased renal function or hypersensitivity to magnesium 
• Were pregnant or nursing
• Were receiving antineoplastic chemotherapy or other investigational drugs within 4 weeks prior to study 
• Had an addition or change of androgens, estrogens, progestins, gabapentin, or antidepressants within 4 weeks prior to study entry; or any change in dose of tamoxifen, raloxifene, or aromatase inhibitors within 4 weeks.

Excluded Renal 
 

• SITE: Single site   
• SETTING TYPE: Not specified   
• LOCATION:  Massey Cancer Center - Virginia, USA
   

• PHASE OF CARE: Transition phase after initial treatment
• APPLICATIONS: Late effects & survivorship; End of life and palliative care
   

This was an observational study.

Instruments and assessments included.

• The Symptom Assessment Scale for overall quality of life
• Linear analog scale Quality of Life questionaires
• CTEP toxicities scale to asses toxicity
• Hot flashes diary- 5 weeks
• Self Assessment Scale  (21 questions) Dr Charles Loprinzi
• ECOG Performance Status
   

Hot flash frequency and score were reduced with magnesium.  The average weekly hot flash score decreased by 50.4% from 109.8 (SE, 40.9) to 47.8 (SE, 13.8), p value 0.02. Magnesium does not have effect on overall quality of life. Fatigue and distress due to hot flashes showed modest benefit. Minor side-effects included migraine, headache, and nausea.                          

The findings suggest that oral magnesium supplementation is effective in reducing the severity and frequency of hot flashes in women after treatment for breast cancer

This study used a small sample <30. The study design was not controlled or randomized. There was possible variance in grading side-effects or toxicity. Magnesium should be tested in a larger population

Magnesium may safely decrease hot flashes, with few side effects and low cost.  Further research in use of magnesium supplements is warranted.

To investigate the effectiveness and tolerability of open-label treatment with escitalopram in patients with breast cancer who have major depressive disorder

Patients received escitalopram at 5 mg/day in week 1. After week 1, the dose was adjusted to 5–20 mg/day. Patients were evaluated at baseline, 1, 2, 4, 8, and 12 weeks.

• A total of 79 patients participated in the study. 
• Patients' mean age was 49.1 years.   
• The sample was 100% female.
• All patients had a breast cancer diagnosis.
• Patients met the criteria for a current major depressive episode and scored 16 or higher on the Hospital Anxiety and Depression Scale.
   

Outpatient settings in the Republic of Korea
 

Transition phase after initial treatment

Prospective study

• Hamilton Depression Rating Scale (HAMD) 
• Functional Assessment of Cancer Therapy Breast (FACT-B)
• MD Anderson Symptoms Inventory
• Clinical Global Impression-Severity (CGI-S)
• Distress Thermometer (DT)
   

62 patients were included in the efficacy analysis, and only 45.6% completed the full 12-week study. Dropouts occurred because of lack of efficacy, no symptom improvement, side effects, and unspecified reasons. 34% of the sample dropped out due to lack of effectiveness or no change in symptoms.

Significant decreases were seen at week 1 and forward in HAMD (p < 0.001), DT (p < 0.001), and CGI-S (p < 0.003). FACT-B scores improved after week 2 (p = 0.011). No differences were observed in baseline scores between responders and nonresponders.

No serious adverse events were reported. The most common side effects were dry mouth, drowsiness, constipation, and increased sweating. Sleep disturbance, shortness of breath, and sadness were improved, but pain, fatigue, and anorexia did not improve.

Escitalopram reduced depression in some patients with breast cancer who had major depressive disorder.

• The sample size was small, fewer than 100 participants.
• No control group was used, and the study had an open-label design. 
• The drop-out rate was more than 30% because of lack of effect. 
• The study was, as the authors said, \"underpowered.\"
   

Escitalopram may be an effective treatment for symptoms of depression in some patients with breast cancer; however, about a third of patients in the study did not experience an effect. Nurses should be aware of side effects that may worsen existing symptoms.

To assess the effects of foot bathing and foot massage for chemotherapy-induced peripheral neuropathy

Patients receiving taxane- or platinum-based chemotherapy were alternately assigned to receive foot baths or foot massage. Both interventions were performed for 30 minutes three times every other day during the patients' hospital stay and five additional times in the home. When at home, phone calls were made to encourage compliance with the intervention. Primary caregivers were instructed in procedures. Study assessments were conducted after the first and eighth treatments. A water temperature of 40 degrees centigrade was used for foot baths.

• N = 48   
• MEAN AGE = 58.94 years
• MALES: 58.33%, FEMALES: 41.67%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Stomach or colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: One-fourth were receiving gabapentin, and one-third were using opioids, for pain.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Republic of Korea

PHASE OF CARE: Active antitumor treatment

Two-group, prospective trial

• Forehead and foot skin temperatures
• Common Terminology Criteria for Adverse Events (CTCAE) toxicity scale for sensory items only
• Functional Assessment for Cancer Therapy Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NT) for quality of life

Foot skin temperature increased about 2 degrees in patients receiving the foot baths and increased less than 1 degree in those receiving foot massage (p = 0.001). There was no significant difference between the groups in grade of sensory neurotoxicity. Those receiving the foot bath reported improved emotional and functional well-being (p < 0.02).

Neither foot baths nor foot massage resulted in improvement in sensory neurotoxicity scores. Those receiving foot baths had increased skin temperature immediately after the intervention and reported improved well-being.

• 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
• Measurement validity/reliability questionable
• Chemotherapy-induced peripheral neuropathy measurement not very sensitive
• No information as to whether any medications for neuropathic symptoms changed over the course of the study

Foot baths and foot massage did not demonstrate results in improvement in sensory symptoms in this study. Patients may experience an improved sense of well-being with foot baths.