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Khedr, E.M., Kotb, H.I., Mostafa, M.G., Mohamad, M.F., Amr, S.A., Ahmed, M.A., . . . Kamal, S.M. (2015). Repetitive transcranial magnetic stimulation in neuropathic pain secondary to malignancy: A randomized clinical trial. European Journal of Pain, 19, 519–527. 

Study Purpose

To evaluate the effects of transcranial magnetic stimulation on neuropathic pain

Intervention Characteristics/Basic Study Process

Patients with neuropathic pain by standardized assessment were randomized to receive either transcranial magnetic stimulation or sham stimulation. After the identification of optimal scalp location, electrodes were used to apply 20 Hz in pulses every day for 10 consecutive days. Procedures for the actual and sham procedures were the same. Study measurements were done before and after the first, fifth, and tenth sessions, and at 15 days and one month later.

Sample Characteristics

  • N = 30
  • MEAN AGE = 47.5 years
  • MALES: Not provided        
  • FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Postmastectomy neuropathic pain; soft tissue sarcoma; giant cell glioma

Setting

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

Study Design

Randomized, sham-controlled trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain

Results

An analysis showed pain reductions in both groups over time, but there were significantly greater pain reductions in the actual stimulation group compared to the sham procedure (p = 0.0001). T tests between groups at each time point showed that there was no real effect of the actual stimulation procedure after the first session. At this point, pain declined and remained stable over time. These effects remained at 15 days but did not remain at one month.

Conclusions

Transcranial stimulation resulted in significant reductions in neuropathic pain. Because the main change occurred after the first session, it was not clear if repeated sessions were beneficial.

Limitations

  • Small sample (< 100)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: No information was provided regarding analgesic use.

Nursing Implications

The findings of this study suggested that transcranial stimulation can reduce neuropathic pain in patients with cancer. This is a noninvasive technique that may provide an important alternative for pain control. Additional research is needed to determine most effective dosing, timing, and efficacy in comparison to other interventions.

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Khan, F., Amatya, B., Pallant, J.F., Rajapaksa, I., & Brand, C. (2012). Multidisciplinary rehabilitation in women following breast cancer treatment: A randomized controlled trial. Journal of Rehabilitation Medicine, 44, 788–794.

Study Purpose

To assess effectiveness of an ambulatory rehabilitation program for women with breast cancer

Intervention Characteristics/Basic Study Process

A sample of patients referred to a rehabilitation center was selected based on criteria of diagnosis of breast cancer, considered to be disease free. Patients were then randomly assigned to an intervention group or a control group that continued with usual activity in the community. The rehabilitation program was conducted three to five days per week for up to eight weeks and was aimed at improving activity and participation in activities. Interventions included physiotherapy, lymphedema care, occupational therapy, and clinical psychology for counseling and support. Study assessments were done at baseline and at four months after program completion.

Sample Characteristics

  • The study reported on a sample of 79 female patients with breast cancer.
  • Median patient age was 57 years (range = 33–80).
  • About half of the patients had undergone mastectomy, while 66% in the intervention group and 55% in the control group had undergone lumpectomy. More patients in the intervention group had received chemotherapy, and slightly more than 70% in both groups had received radiotherapy.
  • More than half (62%) of patients were married or partnered; 63% in the intervention group versus 38% in the control group had tertiary level education.
  • At baseline, depression scores were higher in the intervention group.
  • Duration of disease was 2.3 years in the intervention group and 4.0 years among controls, ranging from < 1 to 24 years.

Setting

  • Single site
  • Outpatient setting
  • Australia

Phase of Care and Clinical Applications

Patients were undergoing multiple phases of care.

Study Design

A randomized, single-blind, controlled trial design was used.

Measurement Instruments/Methods

  • Depression Anxiety Distress Scale
  • Perceived Impact of Problems Profile
  • Cancer Rehabilitation Evaluation System Short Form
  • Functional Independent Measure (FIM)

Results

Out of 42 patients, 31 completed the rehabilitation program. Over the study period, more patients in the treatment group showed a decrease in depression scores compared with the control group (p = 0.02). Intervention group patients also showed significant differences in impact profile scores (p = 0.05). There were no differences between groups in anxiety or FIM scores.

Conclusions

Findings suggest that comprehensive multidisciplinary rehabilitation may improve depression among women with breast cancer.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The study had baseline sample/group differences of import that could have influenced results.
  • Risk of bias existed due to no blinding, no appropriate attentional control condition, and sample characteristics.
  • Subject withdrawals were ≥ 10%.
  • Of the intervention group patients, 26% did not complete the rehabilitation program, leading to the question of practicality and acceptability of this approach for patients.
  • Intervention group patients were more depressed at baseline; other studies have shown that interventions for depression tend to work better for individuals who actually have clinically relevant depression. It is not known if there could have been a floor effect in measurement used.
  • Intervention group patients were more educated. 
  • More control group patients had symptoms such as phantom breast sensations and phantom breast pain, which might have influenced findings.
  • Given differences in the prevalence of some demographic factors, it is surprising that differences were not significant. 
  • There was a very broad range of time since diagnosis, suggesting very broad differences in the sample that were not taken into account.

Nursing Implications

Some patients may benefit from a multidisciplinary rehabilitation program after breast cancer treatment. This study provides some evidence in support of this approach, but has several limitations. Further research is needed to determine the benefit versus cost of such programs.

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Khan, F., Amatya, B., Drummond, K., & Galea, M. (2014). Effectiveness of integrated multidisciplinary rehabilitation in primary brain cancer survivors in an Australian community cohort: A controlled clinical trial. Journal of Rehabilitation Medicine, 46, 754–760. 

Study Purpose

To evaluate the effectiveness of a multidisciplinary rehabilitation program for individuals after treatment for primary brain tumors

Intervention Characteristics/Basic Study Process

Patients were assigned to treatment or wait-list control comparison groups according to an assessment of their needs by the clinical provider. The rehabilitation treatment team was blinded to study group assignment. The intervention included individualized 30-minute therapy sessions with social, psychological, occupational, and physical therapy in half-hour sessions two to three times a week for as many as eight weeks. The individualized intervention incorporated elements of education, health promotion, intensive mobilization, and task reacquisition programs as determined appropriate by the rehabilitation team. Study assessments were done at baseline and at three and six months. Functional independence measures were the primary outcomes of the study.

Sample Characteristics

  • N = 106 (85 completed the six-month assessment)
  • MEAN AGE = 51.4 years (range = 21–77 years)
  • MALES: 43%, FEMALES: 57%
  • KEY DISEASE CHARACTERISTICS: Primary brain tumors with a median time since diagnosis of 2.1 years; all received initial treatment involving surgery, chemotherapy, and/or radiation therapy; 53% of subjects in both groups had World Health Organization grade III or IV tumors and similar rates of steroid use; intervention group reported more symptoms at baseline (i.e., ataxia, cognitive impairment, seizures, paresis, visual impairment, dysphasia, dysarthria, sensory-perceptual deficits, bowel or bladder dysfunction) than the wait-list control group; proportion of patients with ataxia, dysarthria, and visual impairment was significantly larger in the intervention group
  • OTHER KEY SAMPLE CHARACTERISTICS: More than 80% of participants in both groups were living with a partner, and the majority had at least a secondary level education.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Prospective trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain
  • Cancer Rehabilitation Evaluation System Short Form (CARES-SF)
  • Depression Anxiety Stress Scale (DASS)
  • Functional Independence Measures (FIM) for motor skills and cognition
  • Perceived Impact of Problem Profile (PIPP)

Results

At three months, FIM Motor (self-care, sphincter, location, and mobility subscales) and FIM Cognition (communication and psychosocial subscales) scores were significantly improved in the treatment group compared to the control group. At six months, the FIM Motor (sphincter subscale) and FIM Cognition (communication, psychosocial, and cognition subscales) scores were significantly improved in the treatment group compared to the control group. There were no significant differences between groups in DASS measures of anxiety or depression from baseline to three or six months. There also were no differences observed between groups in PIPP results from baseline to three or six months, which measured the impact of functional areas also on the FIM. The greatest improvements seen were at the three-month follow-up date.

Conclusions

The findings of this study demonstrated that multicomponent rehabilitation can improve measures of self-care and some specific areas of motor and cognitive function.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Selective outcomes reporting
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Functional independence was higher at baseline in the wait-list control group by study design, because those with more obvious needs were given the intervention immediately. Therefore, the scoring of function by the control group may have been subject to a ceiling effect in the study measure. Results regarding motor and cognitive function were based on single subscales of the FIM assessment measure with no confirmatory data from a more objective measurement. It is not clear how many patients may have been receiving chemotherapy or radiation therapy during the timeframe of this study, which also could have affected outcome measurements. The fact that findings on perception of impact did not align with FIM results calls into question the overall reliability of findings. The findings are specific to patients with brain tumors and are not necessarily generalizable to other groups.
 

 

Nursing Implications

The findings of this study showed some functional benefits of multicomponent rehabilitation for patients with primary brain tumors. This study was limited by its design and the clinical nature of rehabilitation aimed to provide individualized interventions on the basis of needs assessed by care providers. This suggests that patients may benefit in the areas of self-care. The degree to which these benefits are maintained over time is not clear from this study.

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Khamales, S., Bethune-Volters, A., Chidiac, J., Bensaoula, O., Delgado, A., & Di Palma, M.. (2006). A randomized, double-blind trial assessing the efficacy and safety of sublingual metopimazine and ondansetron in the prophylaxis of chemotherapy-induced delayed emesis. Anticancer Drugs, 17(2), 217-224.

Study Purpose

To compare the efficacy and safety of sublingual metopimazine to ondansetron orally disintegrating tablet (ODT) in patients receiving highly emetogenic chemotherapy (HEC) for the prevention of delayed (not acute) chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Participants were randomized to one of two treatment arms. In group 1, patients received 7.5 mg sublingual metopimazine every eight hours on days 2–6, and, in group 2, patients received ODT ondansetron on days 2–6.

Sample Characteristics

  • The study consisted of 210 participants.
  • The sublingual metopimazine group had 103 patients, and the ODT ondansetron group had 97 patients.

Measurement Instruments/Methods

  • Patients recorded symptoms in daily diaries.
  • The Functional Living Index–Emesis (FLIE) was used.

Results

No significant differences were found between the two groups in control of delayed CINV, quality of life (QOL), or safety; however, control of delayed CINV was inferior compared to other studies.

Limitations

  • This study evaluated an “old” regimen that has since been considered suboptimal care per current consensus guidelines because of availability of newer, superior agents.
  • Corticosteroids were not allowed in the study.
  • The overall dose of metopimazine was low (ineffective).
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Keyhanian, S., Taziki, O., Saravi, M.M., & Fotokian, Z. (2009). A randomized comparison of granisetron plus dexamethasone with granisetron alone for the control of acute chemotherapy-induced emesis and nausea. International Journal of Hematology-Oncology and Stem Cell Research, 3, 27–30.

Study Purpose

To compare granisetron plus dexamethasone to granisetron alone in the prevention of acute emesis

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive either granisetron alone or in combination with dexamethasone. One group received a single IV dose of 3 mg granisetron and the other group received 3 mg IV granisetron and 8 mg IV dexamethasone 30 minutes prior to chemotherapy. Patients were evaluated for 24 hours. Efficacy was determined according to a scale established by investigators.

Sample Characteristics

  • The study consisted of 125 participants, 63 in the granisetron only group (group 1) and 62 in the granisetron plus dexamethasone group (group 2).
  • Median age was 64 years old in group 1, with a range of 40–72 years, and 63 years old in group 2, with a range of 20–70 years.
  • The granisetron group was 33% female and the granisetron plus dexamethasone group was 40% female.
  • Cancer diagnoses were GI, breast, and hematologic.
  • The majority of patients (79% in group 1 and 77% in group 2) were receiving more than 60 mg/m2 of cisplatin.

Setting

The study was conducted at a single setting in Iran.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized, single-blind, prospective study.

Measurement Instruments/Methods

The number of emetic episodes was recorded. Complete response was defined as no emetic episodes.

The investigators developed a scale to record efficacy of the intervention with \"moderately effective\" defined as \"did not interfere with daily life,\" \"slightly effective\" as \"interfered with normal daily life,\" and \"not effective\" as \"bedridden due to nausea.\"

Results

A higher percentage of patients (66.7%) in the group receiving both granisetron and dexamethasone had 0 emesis episodes, compared to fewer than half (42.8%) of patients who received granisetron alone (p < 0.0001).

Conclusions

The combination of granisetron plus dexamethasone was superior to granisetron alone for prevention of acute emesis.

Limitations

  • Minimal information was provided on the chemotherapeutic regimens used.
  • The authors did not indicate if patients were chemotherapy naïve.
  • Some data, such as age ranges and average reported, were different in the abstract than the body of the article, leading to questionable overall report.
  • No valid, common measure of nausea and vomiting was used, and how this was recorded was not clear.

Nursing Implications

Findings indicate that dexamethasone should be included in antiemetic regimens, which is consistent with current care standards.

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Kesler, S., Hadi Hosseini, S.M., Heckler, C., Janelsins, M., Palesh, O., Mustian, K., & Morrow, G. (2013). Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clinical Breast Cancer, 13, 299-306.

Study Purpose

To test the feasibility and effectiveness of a computerized home-based cognitive intervention program

Intervention Characteristics/Basic Study Process

Subjects were randomly assigned to the intervention group or a wait-list control group. The intervention was a 12-week computerized training program (Lumos Labs) using the subjects' home computers. It included 48 sessions that were 20-30 minutes long, involving combinations of 13 exercises to improve executive function. Subjects were assigned five exercises to complete four times per week. Exercises were designed for practice and training in cognitive flexibility, working memory, processing speed, and verbal fluency.  Completion, duration and performance of exercises were recorded in the computer system, providing an adherence measure. Outcome measures were collected at baseline and within three days of intervention completion; wait-list controls had pre-post measures taken 12 weeks apart.

Sample Characteristics

  • N = 41    
  • MEAN AGE = 55.5 years (SD = 0.5 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All subjects had stage I-IIIA  breast cancer, received surgical intervention and adjuvant chemotherapy, and completed treatment at least 18 months prior to study participation.
  • OTHER KEY SAMPLE CHARACTERISTICS: Subjects had at least a high school education; 60%-70% also received radiation therapy and hormonal therapies.

Setting

  • SITE: Single site    
  • SETTING TYPE: Home  

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Wisconsin Card Sorting Test (WCST)
  • Delis-Kaplan Executive Functions System, Letter Fluency Test
  • Hopkins Verbal Learning Test Revised
  • Wechsler Adult Intelligence Scale (digit span and symbol search subscales)
  • Behavioral Rating Inventory of Executive Function (Global Executive Composite score)
  • Clinical Assessment of Depression

Results

There was 95% compliance with the training program. The intervention group had significant improvement as shown by Cohen’s d, the WCST (EF = 0.58, P = .008), the Letter Fluency Test (EF = 0.82, P = .003), and symbol search (EF = 0.87, P = .009). While there were no significant effects of age, education, radiation, or hormonal treatment, presence of depressive symptoms had a significant effect on self-reported global executive function.

Conclusions

This approach for training and home-based exercises is feasible, and compliance was high. The program was effective for improving some components of executive function. Further study with longitudinal measures is warranted to demonstrate maintained improvements in cognitive function after program completion or if continued program use is needed to maintain any improvements.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Intervention expensive, impractical, or needs training
  • The computerized training cost was covered by the research study; however, it is commercially available for individual cost, which may be an issue for some patients. The sample was a homogenous group of patients, potentially limiting generalizability to other patient groups.

Nursing Implications

The commercially available computerized “brain training” program studied here improved components of executive function after 12 weeks. This approach was associated with high patient compliance. Nurses can suggest that patients complaining of cognitive impairment consider trying this program.

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Keskinbora, K., Pekel, A.F., & Aydinli, I. (2007). Gabapentin and an opioid combination versus opioid alone for the management of neuropathic cancer pain: A randomized open trial. Journal of Pain and Symptom Management, 34, 183–189. 

Study Purpose

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.

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • 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.

Setting

The study was conducted in Turkey.

Study Design

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

Measurement Instruments/Methods

  • 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.

Results

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.

Conclusions

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.

Limitations

  • 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.

Nursing Implications

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

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Keskinbora, K., Pekel, A.F., & Aydinli, I. (2007). Gabapentin and an opioid combination versus opioid alone for the management of neuropathic cancer pain: A randomized open trial. Journal of Pain and Symptom Management, 34, 183–189.

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • 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.

Setting

  • Single site
  • Turkey

Study Design

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

Measurement Instruments/Methods

  • 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

Results

  • 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.

Conclusions

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.

Limitations

  • 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.
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Keogh, J. W., & MacLeod, R. D. (2012). Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. Journal of Pain and Symptom Management, 43, 96–110.

Purpose

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

Search Strategy

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.

Literature Evaluated

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.

Sample Characteristics

  • 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.

Results

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.

Conclusions

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.

Nursing Implications

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.

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Kennedy, M., Bruninga, K., Mutlu, E.A., Losurdo, J., Choudhary, S., & Keshavarzian, A. (2001). Successful and sustained treatment of chronic radiation proctitis with antioxidant vitamins E and C. American Journal of Gastroenterology, 96(4), 1080–1084.

Study Purpose

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

Intervention Characteristics/Basic Study Process

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

Sample Characteristics

  • 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.

Study Design

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

Measurement Instruments/Methods

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.

Results

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.

Limitations

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

Nursing Implications

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

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