The objective of this study was to compare the safety and efficacy of gabapentin with opioid versus opioid monotherapy for the management of neuropathic pain.

Patients were randomized to one of two groups: Group GO included gabapentin added to ongoing opioids, gabapentin titrated to pain, and opioids kept constant; group OO saw the continuation of opioid monotherapy using the World Health Organization ladder approach.

Regarding dosing, gabapentin was initially given at 100 mg three times daily for patients aged 60 and older and 300 mg three times daily for those younger than age 60. Doses were titrated over the three days—up to 3,600 mg per day according to response. Patients in the GO group also could take gabapentin as a rescue drug.

• Seventy-five patients who were receiving opioids with minimal opioid side effects and had unrelieved neuropathic pain were enrolled in the study.
• A total of 63 patients completed the trial.
• Patients had a Karnofsky score higher than 60 and pain intensity rated as 4 or greater.
• Potential participants were excluded if they were taking adjuvant drugs and nonopioid analgesics.
• Patients were removed from the study if new pain from disease progression occurred or if intolerable side effects developed.

The study was conducted in Turkey.

The study was a randomized, single-site, open trial.

• Pain intensity, specifically burning and shooting, was recorded with a numeric rating scale.
• The mean absolute change in pain intensity was recorded at day 13.
• Allodynia and analgesic drug consumption, including rescue, were evaluated at days 4 and 13. Side effects also were recorded.
• Allodynia was assessed by a light cotton material being stroked on painful and non-painful areas. Allodynia was said to be present if a normal response was noted in non-painful areas but pain or an unpleasant sensation was noted in the painful area.

Both groups (GO and OO) saw a significant reduction in pain intensity on days 4 and 13 compared to baseline. The mean pain intensity for burning or shooting pain was significantly higher in group OO compared to group GO at both assessment times (p = 0.0001); however, a clinically meaningful reduction was noted in group OO. In addition, a significant decrease in allogynia was seen in the GO group at day 4 (p = 0.002) and the rate of side effects was significantly lower in GO (p = 0.015). Of note, one patient in the GO group withdrew from the study due to respiratory depression. The patient was taking gabapentin and SR morphine and was age 66. Depression occurred three days after gabapentin was added.

The most frequent causes of pain included malignant sacral plexopathy (32%) in group GO and brachial plexopathy (28%) in group OO. Patients in the GO group remained at the same step of the ladder at day 4; group OO patients who took weak opioid at the second step all progressed to the third step. This may explain less SE in the GO group.

The findings suggest that gabapentin added to opioids provides better relief than opioid monotherapy alone and may represent a potential first-line treatment for these patients. Gabapentin added to opioids may create a synergistic effect. Gabapentin also may extend opioid efficacy.

• The measurement of allodynia was seen as a limitation, as were the primary neuropathic syndromes being different in each group.
• The World Health Organization ladder has been abandoned by many practitioners in favor of National Comprehensive Cancer Network or American Pain Society guidelines.

Nurses should be aware of possible respiratory depression when patients are treated with gabapentin and morphine, particularly older adult patients.

To compare a gabapentin-opioid combination to opioid monotherapy, in terms of safety and efficacy, in the management of neuropathic pain

Patients were randomized to one of two groups. One group received treatment with gabapentin added to ongoing opioids. Gabapentin was gabapentin titrated to pain; in this group (group GO), opioids were kept constant. In the other group (group OO), opioid monotherapy was continued according to the World Health Organization (WHO) ladder approach. The initial gabapentin dose was 100 mg three times daily for patients older than age 60 and 300 mg TID for those younger than age 60. Treatment was titrated to these doses in three days and to 3,600 mg per day according to response. GO patients could take gabapentin as a rescue drug.

• The sample was comprised of 75 patients who were receiving opioids with minimal opioid side effects and had unrelieved neuropathic pain; 63 patients completed the trial.
• All patients had a Karnofsky Performance Status score greater than 60 and a pain intensity score of 4 or higher.
• Patients were excluded from the study if they were taking adjuvant drugs and nonopioid analgesics.
• Patients were removed from the study if new pain from disease progression occurred or if intolerable side effects developed.

• Single site
• Turkey

The study was a randomized, single-site, open trial.

• Numeric rating scale (NRS) to measure pain intensity, specifically burning and shooting
• Mean absolute change in pain intensity at day 13
• Allodynia (Allodynia was assessed by stroking painful and nonpainful areas with a light cotton material. If normal response was noted in nonpainful area but pain or unpleasant sensation was noted in painful area, allodynia was said to be present.)
• Analgesic drug consumption, including rescue, evaluated on day 4 and day 13
• Side effects

• Both treatments resulted in significant reduction in pain intensity on day 4 and day 13, compared to baseline.
• Mean pain intensity for burning or shooting pain was significantly higher in group OO than in group GO at both assessment times (p = 0.0001). However, there was a clinically meaningful reduction in group OO.
• Data showed a significant decrease in allodynia (p = 0.002) in group GO at day 4.
• The rate of side effects was significantly lower (p = 0.015) in group GO.
• One patient in the group GO withdrew from the study because of respiratory depression. The patient was taking gabapentin and sustained-release morphine and was age 66. Depression occurred three days after the addition of gabapentin. Respiratory depression should be considered when using gabapentin and morphine, particularly in older adults.
• In terms of the most frequent causes of pain, 32.3% of GO patients had malignant sacral plexopathy, and 28.15% of OO patients had brachial plexopathy.
• GO patients remained at the same step of the ladder at day 4. Group OO patients, who took a weak opioid at the second step, all progressed to the third step. This may explain why fewer patients in group GO experienced side effects.

This study suggests that gabapentin added to opioids provides better relief than opioid monotherapy. Gabapentin-opioid treatment may be a first-line treatment for the specified patients.

• The means of measuring allodynia are questionable.
• The primary neuropathic syndromes were different in each group.
• The WHO ladder has been abandoned by many practitioners, who now follow National Comprehensive Cancer Network or American Pain Society guidelines.

To systematically review the literature for benefits of exercise in patients with prostate cancer.

Databases searched were PubMed, CINAHL, and Google Scholar.

Search keywords were exercise, physical activity, prostate cancer, and training and all word derivatives.

Studies were included if they 

• Were full, published articles
• Included patients with prostate cancer
• Involved an exercise intervention of at least four weeks duration
• Reported changes in body composition, fitness, quality of life (QOL), and/or fatigue.

The total volume of studies retrieved and excluded was not provided. An adaptation of methods reported by Sackett was used to evaluate methodological rigor, involving six criteria. How the criteria were applied by investigators was not described.

• A sample of 12 studies was included, involving a total of 360 patients.
• Study sample sizes ranged from 10 to 82 patients.
• All patients had prostate cancer.
• Demographics were not reported in all studies used; however, most patients were said to be Caucasian, married, and between ages 66 and 72 years.

Seven studies reported group-based exercise. The authors reported that most of these patients showed significant improvement in some QOL measures and fatigue.  Five studies reported home-based exercise. These showed no significant increase in QOL, and two of these reported significant reduction in fatigue.  Resistance, aerobic, and combined types of exercise appeared to be similarly effective. The timing of exercise interventions related to cancer treatment were not described. Comparative findings regarding changes in muscle strength and endurance were provided.

There is relatively strong to strong evidence that exercise performed a minimum of two to three days per week can significantly improve physical fitness, functional performance, and QOL and reduce fatigue in patients with prostate cancer.

The context in which the exercise was performed and type of exercise (aerobic, resistance, or combined) may mediate the magnitude of benefit derived.  Group-based exercise appeared to offer greater benefit than home-based programs in the studies included.

Findings suggested that exercise recommendations should be a part of care for survivors of prostate cancer for fitness, QOL, and fatigue benefits. Group-based activity may have greater benefit than individual home-based exercise recommendations.

To determine whether antioxidant vitamins, by counteracting oxygen-free radical injury, would relieve symptoms of chronic radiation proctitis

Patients received 400 IU vitamin E and 500 mg vitamin C three times per day for eight weeks.

• This study reported on 20 consecutive patients (10 prostate cancer survivors and 10 gynecologic cancer survivors) from a single gastroenterology clinic. 
• Patients were experiencing persistent, postradiation proctitis with disabling diarrhea, urgency, or fecal incontinence.

This study used a nonrandomized, before-and-after design in which patients served as their own controls.

Patients completed questionnaires that assessed severity, frequency, and lifestyle impact of four factors (rectal bleeding, rectal pain, diarrhea, and fecal urgency) with each factor rated on a five point, Likert-type scale ranging from 0–4.

The majority of patients (14 out of 16) reported less diarrhea, and eight said diarrhea stopped completely. Among patients with rectal bleeding or urgency, symptoms completely resolved in 36% and 19%, respectively. Lifestyle improved in 13 patients, and seven reported a return to normal.

The study is limited because it is nonrandomized and noncontrolled, involves a single clinic, and has a small sample size.

The use of vitamins E and C to manage radiation-induced diarrhea symptoms represents a low risk of harm.

Researchers sought to show that  some SSRI antidepressants reduce tamoxifen’s effectiveness by inhibiting its bioactivation by cytochrome P450 2D6 (CYP2D6).

The study enrolled postmenopausal women with breast cancer using tamoxifen therapy and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine.)

The study included women living in Ontariowho were 66 years or olderand treated with tamoxifen for breast cancer between 1993 and 2005 and with a single SSRI. (24,430 women were identified; 2,430 entered into study; mean age was 74 years).

Inclusion criteria: Postmenopausal women with breast cancer newly treated with tamoxifen (defined as no tamoxifen prescription in the preceding year) and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine)

Exclusion criteria: Antidepressant use of duloxetine or escitalopram

Ontario Cancer Registry provided the data.

This was a retrospective cohort study.

The study examines the total duration of tamoxifen therapy (index date: date tamoxifen was last dispensed plus an additional 60 days) and the extent to which co-prescription of potentially interacting medications occurred during the course of treatment. The primary outcome was death from breast cancer

Of 2,430 women treated with tamoxifen and single SSRI, 374 (15%) died of breast cancer during follow up. Absolute increases of 25%, 50%, and 75% in the proportion of time on tamoxifen overlappingthe  use of paroxetine were associated with 24%, 54%, & 91% increases in the risk of death from breast cancer. (p < 0.05) No such risk was seen with other antidepressants

Reported study limitations included lack of information on breast cancer stage and lack of information on indication for antidepressant use.

This intervention was therapeutic touch (TT). The experimental group received 10 minutes of TT and 20 minutes of dialogue, and the control group received 10 minutes of quiet time and 20 minutes of dialogue. Data were collected as part of a larger experimental study of the effects of TT on pre- and postoperative anxiety and mood and pain in women with breast cancer. Telephone interviews were conducted at the completion of an experimental or control nursing intervention administered in the women’s homes before and after breast cancer surgery. The interview consisted of six open-ended questions.

The study reported on a sample of 18 women with early-stage breast cancer.

Mixed methods of qualitative and quantitative study were used.

Telephone interviews consisting of six open-ended questions

Regardless of experimental or control intervention, women expressed feelings of calmness, relaxation, security, and comfort. No objective measures were reported.

• Validity and reliability of measures are unknown.
• The study had a very small sample size.

To evaluate irinotecan disposition and pharmacodynamics in the presence and absence of the broad-spectrum antibiotic neomycin

Patients experiencing grade 2 or higher diarrhea after receiving irinotecan alone (350 mg/m² every 3 weeks) received the same dose combined with 1,000 mg oral neomycin three times per day continuously from 2 days prior to 5 days after the second course.

The study reported on 20 patients with advanced colorectal cancer receiving CPT-11 (350 mg/m² every 3 weeks).

This was a nonrandomized trial. Patients acted as their own controls.

Presence of more than 4 stools per day and duration (measured in days) of diarrhea were recorded.

• Nine patients developed grade 2 diarrhea in the first chemotherapy course and were then given neomycin as cotreatment in the second course of chemotherapy.
• No significant effect was found on hematological toxicity (p > 0.05), but diarrhea improved in six out of seven patients (p = 0.033).

Findings indicate that bacterial B-glucorinidase plays a crucial role in irinotecan-induced diarrhea without affecting enterocycling and systemic SN-38 levels.
 

This was an extremely small pilot study.

STUDY PURPOSE: To evaluate published evidence regarding the effects of music on cancer-related pain 

• FINAL NUMBER STUDIES INCLUDED =  5
• TOTAL PATIENTS INCLUDED IN REVIEW = 248
• SAMPLE RANGE ACROSS STUDIES: 9–126 patients

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

Out of the five studies included, two showed significant differences in self-reported pain scores associated with the music intervention. Most studies were done outside of the United States, and in most studies, patients were offered a limited variety of prerecorded music for listening.

This review showed mixed results regarding the effects of listening to music on pain among patients with cancer in various phases of care.

• There were few studies included.
• There was no evaluation of study quality.
• Three out of five studies were done prior to 2000.

This review did not add substantially to the body of evidence regarding the use of music for cancer-related pain. There are a number of more recent studies that have shown greater efficacy and are of higher quality than those reviewed here.

To determine the effects of treatments for nausea and vomiting either as a result of the disease or its treatment in adults with cancer and other chronic diseases

Databases reviewed searched were MEDLINE, Embase, and the Cochrane database. Harm alerts from the Food and Drug Administration (FDA) and the United Kingdom regulatory agency also were reviewed.

No separate description of the volume of literature evaluated or the specific evaluation process was provided. The Grading of Recommendations Assessment, Development and Evaluation (GRADES) system was used for rating the evidence, and these results were provided. The literature review was completed as of April 2008.

The study reported on 13 randomized, controlled trials (RCTs), representing more than 14,000 patients with cancer. These included studies of nausea and vomiting as a result of disease or treatment.

Results indicated that 5-HT₃ RAs + dexamethasone was beneficial.

The following were identified as likely to be beneficial.

• 5-HT₃ RAs + corticosteroid with radiotherapy-induced nausea and vomiting
• Aprepitant added to conventional regimens
• Haloperidol
• Metoclopramide for chemotherapy-induced nausea and vomiting (CINV)
• Phenothiazines
• Venting gastrostomies

Cannabinoids were identified as being a tradeoff between benefit and harm.

The following were determined to have unknown effectiveness.

• 5-HT₃ receptor antagonists (RAs) for radiation-induced nausea and vomiting
• Antihistamines
• Antimuscarinics
• Antipsychotics
• Benzodiazepines for CINV

• Although no evidence was identified, and, at this writing, there was a stated drug safety alert on haloperidol, this review identified haloperidol as likely to be beneficial. It is unclear how this can meet this category.
• Results cited tended to focus on vomiting episodes and did not address the symptom of nausea.
• Results were a mix of symptoms from the disease itself or treatment, so differentiation of applicability was not always clear.
• Some aspects of the search strategy were unclear.
• Some interventions stated that no RCTs or systematic reviews were found, so no evidence was provided; however, in other areas, observational studies and consensus opinions were cited as supporting evidence.
• Inclusion and exclusions were not stated.
• No information was included on nonpharmacologic interventions in combination with antiemetic regimens.

Intervention goals were to

1. Educate patient/partner dyads about cancer pain and management.
2. Teach dyads a variety of pain coping strategies.
3. Teach partners how to help patients acquire and maintain coping skills.

Three 45- to 60-minute face-to-face sessions with an RN educator for training in pain management strategies were delivered over one to two weeks. Educators were knowledgeable about cancer pain and skilled in coping skills training interventions. Four educators were used, and quality assurance plans were described.

• In session 1, the training program and materials were explained, a videotape was shown, and a book was given regarding barriers, treatments, side effects, and healthcare provider communication.
• In session 2, participants received relaxation training and guided imagery.
• In session 3, an activity pacing method was introduced.

For sessions 2 and 3, the educator guided participants through skills, partners were asked to serve as coach, and the educator provided feedback.

Following completion of the three sessions, the educator reviewed the coping skills found most useful and developed a maintenance plan.

• The sample (N = 78) was comprised of patient/partner dyads.
• Participants were assigned to the intervention group (n = 41) or a control group (n = 37) receiving standard care through their medical outpatient or hospice program.
• Patients had advanced cancer diagnoses and were experiencing disease-related pain (worst pain rating of > 3 on the Brief Pain Inventory), a life expectancy of less than six months, and no change in their disease treatment planned.
• Patients were older than 18 years of age and met Medicare hospice benefit eligibility criteria (regardless of enrollment).

Home setting

A properly randomized, controlled trial design was used (with small sample size). Power analysis was not reported.

• Caregiver Strain Index
• Chronic Pain Self-Efficacy Scale (for caregivers)
• Profile of Mood States–Brief

A trend toward reporting lower levels of caregiver strain (p = 0.06) existed.

Partners receiving the intervention reported significantly higher levels of self-efficacy for helping patients control pain and significantly higher levels of self-efficacy for helping patients control other symptoms.

No significant difference was found in positive or negative mood.

• The sample size was small.
• The study had high attrition rates (31.7% in the intervention group and 24.3% in the control group).