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Lewis, F.M., Casey, S.M., Brandt, P.A., Shands, M.E., & Zahlis, E.H. (2006). The Enhancing Connections program: Pilot study of a cognitive-behavioral intervention for mothers and children affected by breast cancer. Psycho-Oncology, 15(6), 486–497.

Intervention Characteristics/Basic Study Process

The Enhancing Connections program is a five-session multicomponent cognitive behavioral educational counseling intervention delivered at two-week intervals. Each session is scripted and lasts one hour. Components include home-based interactive didactics for mothers, experiential exercises, skilled efficacy-enhancing rehearsals led by a patient educator, mother-child booklets about cancer, mother-child workbooks, and between-session telephone access to a patient educator.

Sample Characteristics

13 mothers with stage 0, I, and II breast cancer and 13 school-age children

Setting

Pacific Northwest of the United States

Study Design

Single-group pre- and post-test design

Measurement Instruments/Methods

Maternal measures: Center for Epidemiological Studies Depression Scale, State-Trait Anxiety Inventory Form Y, and Cancer Self-Efficacy Scale.

Mother-child measures: Relatedness Scale and Family-Peer Relationship Scale.

Child measures: Illness-related Pressures Scale, Cancer-Worries Scale, Disenfranchised Grief Scale, Revised Child Manifest Anxiety Scale, Child’s Depression Inventory, and the Child Behavior Problem Checklist.

Results

The program resulted in significant improvements between baseline and post-test in mother’s depressed mood, state anxiety, and self-efficacy in regard to caring for self and family and dealing with the impact of cancer. For children, the program resulted in significant improvements in behavior and emotional functioning, in anxiety or depressed mood, and in reduction of cancer worries.

Conclusions

Evidence suggests that the Enhancing Connections program helped mother and children improve functioning.

Limitations

  • Single-group design with very small sample.
  • Results do not generalize to mother-child dyads involving children with clinically elevated anxiety or symptoms of depression or to mother-child dyads in which the mother-child relationship is poor. Results should be viewed with caution.
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Lewis, F.M., Cochrane, B.B., Fletcher, K.A., Zahlis, E.H., Shands, M.E., Gralow, J.R., . . . Schmitz, K. (2008). Helping Her Heal: A pilot study of an educational counseling intervention for spouses of women with breast cancer. Psycho-Oncology, 17, 131–137.

Study Purpose

To enhance spouses’ skills and confidence in communicating and interpersonally supporting their wives with breast cancer

To improve spouses’ self-care, depressed mood, anxiety, and marital adjustment

Intervention Characteristics/Basic Study Process

Baseline measures of the six study scales were obtained: depression, spouse skills, anxiety, self-efficacy of spouse, marital quality, and interpersonal sensitivity and mutuality. Five one-hour sessions were scheduled and delivered at two-week intervals. Details of the fully scripted educational counseling intervention session were described, and content was presented in a tabular format. Homework for each participant to complete with his wife was assigned to build skills and enhance efficacy. An exit interview with each participant and his wife was conducted. Post-test measures were taken.

Sample Characteristics

  • The sample (N = 40) was comprised of 20 wives with breast cancer and 20 male spouses. A total of 26 spouses consented and completed baseline inventories, after which 6 spouses dropped out of the study. A total of 20 spouses completed the intervention program and study post-test measures.
  • Mean age of spouses was 53 years (SD = 9.5); mean age of wives was 48 years (SD = 8.6).
  • Of the 20 wives, 19 were Caucasian and one was Black.
  • Of the 20 spouses, 18 were Caucasian, one was Asian, and one declined to specify ethnicity.
  • Wives were diagnosed with local or regional breast cancer (stages 0–III) within the past six months and had been diagnosed an average of 4.1 months at the beginning of the study (median time since diagnosis of 4.2 months).
  • Ten wives (50%) were receiving chemotherapy, radiation therapy, or both at the time the spouses were participating in the study. Types of treatment received were breast-conserving surgery (55%) and surgical (45%), such as partial, radical, or prophylactic mastectomy.
  • Of the sample, 80% of spouses and 85% of wives had college degrees or higher, and 85% of spouses and 70% of wives worked full- or part-time.
  • The average length of marriage was 17.1 years (SD = 10.7), with a median of 14.8 years.
  • Half (50%) of the couples had one child or more living at home.

Setting

  • Multisite
  • Outpatient setting
  • Pacific Northwest: One-hour counseling intervention sessions were scheduled and delivered at two-week intervals in a private clinic room.

Study Design

A pre/post-test pilot study design was used.

Measurement Instruments/Methods

  • Spouse Skills Checklist: This 11-item checklist was developed for the study and included two parts: a 5-item wife support subscale and a 6-item self-care stress management report.
  • Center for Epidemiologic Studies–Depression (CES-D) Scale: This is a 20-item self-report of symptoms, with a score of 16 or higher indicating need of referral for clinical evaluation of depression. Significant (p = 0.001) reduction in depressive symptoms was reported.
  • Spielberger State-Trait Anxiety (STAI-Y) Scale: Significant (p < 0.001) anxiety reduction was reported.
  • Cancer Self-Efficacy Scale–Spouse (CASE-S): Total scale (19-item self-report) spouse skills significantly (p < 0.001) improved. Subscale improvements were also reported.
  • Dyadic Adjustment Scale (DAS): Four subscales measured affectional expression, consensus, cohesion, and satisfaction. There was significant (p = 0.028) improvement on affectional expression, but was not significant on the remaining subscales.
  • Mutuality and Interpersonal Sensitivity Scale (MIS): There were no significant changes in this 32-item measure of cancer-specific marital quality.

Results

Depressed mood and anxiety were significantly (p = 0.001 and p < 0.001, respectively) diminished; self-efficacy was significantly improved; spousal skills were significantly (p < 0.001) improved; and marital quality was significantly (p = 0.028) improved but only on one of the affectional expression subscales. There was no significant improvement on the other subscales of marital quality. There were no significant changes in the cancer-specific measure of marital quality. Spouses verbalized that the educational counseling intervention was helpful, specifically for listening skills.

Conclusions

A brief, structured, skill-focused, efficacy-enhancing educational counseling intervention has the potential to positively affect spouses’ adjustment (mood and anxiety), skills, self-efficacy, and self-care during the diagnosis and treatment phase of their wife’s breast cancer. The program focuses the intervention on the spouse to reduce tension and improve interpersonal communication regarding the wife’s diagnosis, treatment, feelings, and associated emotions.

Limitations

  • The sample was small (< 30).
  • The stated purpose and goals of the study and intervention did not specify the impact on the wives of participants, yet the wife of each participant was included in the exit interview. Wives’ opinions and responses were not included at the beginning of the study, so there was no baseline for comparison of their responses.
  • The sample was primarily white people with relatively long marriages.
  • Whether the exit interviews were conducted before or after the post-test measurements is not entirely clear.

Nursing Implications

The Helping Her Heal program offers promise to assist with building coping skills and support strategies for couples by educational counseling intervention among spouses of people with breast cancer and other chronic conditions.

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Levine, M.E., Gillis, M.G., Koch, S.Y., Voss, A.C., Stern, R.M., & Koch, K.L. (2008). Protein and ginger for the treatment of chemotherapy-induced delayed nausea. Journal of Alternative and Complementary Medicine, 14, 545–551.

Study Purpose

To determine the extent to which protein meals along with ginger, when used as adjuvant therapies for standard antiemetic treatment, reduce delayed nausea

Intervention Characteristics/Basic Study Process

Patients were assigned randomly to 1 of 3 experimental groups. The Protein (P) and High Protein (HP) Groups received test meals of varying protein content and dried powdered ginger root in addition to standard antiemetic medication; the Control Group received only standard antiemetic medication.

The P and HP Groups were asked to consume two test meals daily for three days beginning 24 hours after their first chemotherapy session. Patients in the Control Group consumed their normal diet.

Patients completed daily diaries during the three-day study. Investigators called patients daily to monitor for adverse events, answer questions, remind patients to eat the test meals, and remind them to complete diaries.

Sample Characteristics

  • The study consisted of 28 participants.
  • Patient ages ranged from 29–83 years with a mean of 54.3 years.
  • The majority of patients were female (75%).
  • Cancer diagnoses were breast, Hodgkin and non-Hodgkin lymphoma, bladder, lung, gastric, and prostate.
  • Patients were treated with 13 different chemotherapy regimens using six different types of antiemetics.
  • Patients were receiving their first chemotherapy treatment with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

Setting

The setting was not reported.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized controlled trial, non-blinded study.

Measurement Instruments/Methods

An Electrogastrogram Symptom Diary was used to report nausea symptoms incidence, frequency, and intensity. Patients also recorded use of as-needed antiemetics.

Results

  • Reports of nausea, frequent nausea, and bothersome nausea were significantly less common (p < 0.01) among the HP Group patients than among the Control and P Group patients.
  • Significantly fewer patients in the HP Group used antiemetic medication (p < 0.05). The differences between the P and Control groups were not statistically significant.
  • In the five patients who had tests of gastric myeoelectrical activity performed, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger (p <  0.05).

Conclusions

High-protein meals with ginger reduced delayed nausea associated with chemotherapy and use of antiemetic medications.

Limitations

  • The sample size was small.
  • A standardized measurement tool for report of nausea was not used.
  • Conclusions cannot be drawn on the role of ginger in reducing nausea because of possible interactions between ginger and high doses of protein.
  • Samples were widely variable in terms of cancer types, cytotoxic agents, and prescribed antiemetic medications.
  • The study lacked an adequate control group for the ginger component of the test meals and a placebo meal that contained neither ginger nor protein.
  • Daily phone calls to patients from investigators may have skewed results.

Nursing Implications

The limitations of this study limit the ability to draw conclusions for nursing practice.

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Levesque, M., Savard, J., Simard, S., Gauthier, J.G., & Ivers, H. (2004). Efficacy of cognitive therapy for depression among women with metastatic cancer: A single-case experimental study. Journal of Behavior Therapy and Experimental Psychiatry, 35, 287–305.

Intervention Characteristics/Basic Study Process

  • Cognitive therapy
    • Baseline phase no intervention
    • Weeks 3–8, patients completed daily mood diary
    • Hospital Anxiety and Depression Scale (HADS) weekly
    • Once eight weekly sessions of cognitive therapy were completed, daily mood diary and HADs weekly

Sample Characteristics

  • N = 6 (3 completed)
  • AGE = 42–66 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Stage IV metastatic breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Beck Depression Inventory (BDI) score of 17 or more or HADS score of 7 or more; at end of life but with more than two months expected to live

Phase of Care and Clinical Applications

  • PHASE OF CARE: End of life

Study Design

  • Single-case experimental design to show efficacy or no efficacy of cognitive therapy for depression in women with metastatic cancer

Measurement Instruments/Methods

  • Fatigue is associated with depression, but which scale was used is not spelled out.

Results

A statistically significant improvement in fatigue level was seen.

Limitations

  • Study not representative
  • Excessive withdrawals
  • A lot of written scales to give someone to complete at end of life
  • Resident in psychiatry was independent psych evaluator; licensed therapists to conduct intervention
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Leung, H.W., & Chan, A.L. (2016). Glutamine in alleviation of radiation-induced severe oral mucositis: A meta-analysis. Nutrition and Cancer, 68, 734–742. 

Purpose

STUDY PURPOSE: To assess the effectiveness of glutamine to treat severe mucositis induced by radiation therapy in patients with head and neck cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Electronic searches of PubMed (1990–January 2015), Embase (1990–January 2015), and the Cochrane Library (2013, issue 2) were used. 
 
INCLUSION CRITERIA: Randomized controlled trials of glutamine to alleviate oral mucositis (OM) in patients with head and neck cancer who received radiotherapy (n = 5)
 
EXCLUSION CRITERIA: Patients who did not have OM (n = 8)

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 28 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The grading approach outlined in the Cochrane Handbook for Systematic Reviews of Interventions and GRADES criteria for evaluation

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 5
  • TOTAL PATIENTS INCLUDED IN REVIEW = 234 patients with head and neck cancer
  • SAMPLE RANGE ACROSS STUDIES: 8–61 patients
  • KEY SAMPLE CHARACTERISTICS: Patients receiving radiation therapy for head and neck cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Elder care

Results

Glutamine treatment had statistically significant benefits: It (a) reduced the risk and severity of OM (grade IV) (RR = 0.17, 95% confidence interval [0.06, 0.47]) and (b) shortened the duration of OM by 2–3 days. The studies reviewed had a low risk of overall bias.

Conclusions

The protective effects of glutamine for radiation and chemotherapy-induced mucositis are promising. Glutamine or alanyl-glutamine accelerated the mucosal recovery through increasing mucosal tissue glutathione stores, reducing inflammatory parameters and speeding re-epithelization.

Limitations

  • Limited search
  • Limited number of studies included
  • Low sample sizes

Nursing Implications

Large prospective, comprehensive clinical trials are needed to investigate the effectiveness of glutamine in the prevention of OM induced by radiation therapy or chemoradiotherapy.

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Leung, N., Furniss, D., & Giele, H. (2015). Modern surgical management of breast cancer therapy related upper limb and breast lymphoedema. Maturitas, 80, 384–390. 

Purpose

STUDY PURPOSE: To consider the risks, benefits, and efficacy of current techniques in preventing or managing upper extremity lymphedema related to breast cancer surgery and to bring focus to more specific research gaps for additional investigation
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE
 
KEYWORDS: Lymphatic vessels, lymphedema, and surgery (related to these)
 
INCLUSION CRITERIA: Published after 2000; only modern surgical techniques; prevention or treatment
 
EXCLUSION CRITERIA: Studies not meeting the criteria for inclusion

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 20,614
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A literature search of MEDLINE from its start to February 2014 was completed. The studies included had to be published after 2000 and either prevent or treat lymphedema secondary to breast cancer treatment. The studies' references also were reviewed for inclusion.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 16
  • TOTAL PATIENTS INCLUDED IN REVIEW = 305 
  • KEY SAMPLE CHARACTERISTICS: Breast cancer patients only; patients with and without lymphedema

Phase of Care and Clinical Applications

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

Results

The most useful procedure out of those reviewed was lymphatic vessel anastomosis. The least recommended was lymph node transfer because of conflicting data and potential complications. The remaining reviewed options would be effective based on individual cases and needs.

Conclusions

  1. More research on lymphatic vessel anastomosis determining the ideal population and parameters for its use is needed.
  2. Better definitions of outcomes and a more specific focus for research and data interpretation are needed.
  3. Standards for the diagnosis and treatment of lymphedema must be improved to identify current and potential patients who may need interventions or prevention.

Limitations

  • No noted method to evaluate the quality of the studies being reviewed

Nursing Implications

The findings of this systematic review showed that initiatives to do primary research and data collection would be useful. This may be an area in which nurses can contribute.

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Leung, E.Y., Tirlapur, S.A., & Meads, C. (2015). The management of secondary lower limb lymphoedema in cancer patients: A systematic review. Palliative Medicine, 29, 112–119. 

Purpose

STUDY PURPOSE: To evaluate the evidence for the treatment of lower limb lymphedema in patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy

  • DATABASES USED: MEDLINE, EMBASE, LILACS, Science Citation Index, Cochrane CENTRAL, International Society of Lymphology, Australian Lymphoedema Association congress proceedings, and SIGLE
  • KEYWORDS: Secondary lymphedema and therapy with medical subject headings (full terms available in article)
  • INCLUSION CRITERIA: Randomized, controlled trials and comparative observational studies including at least 50 participants with cancer
  • EXCLUSION CRITERIA: Studies with no description of treatment effects

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,630
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Randomized, controlled trials were evaluated with the Jadad scale. Observational studies were evaluated with the Newcastle-Ottawa scale.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 7
  • TOTAL PATIENTS INCLUDED IN REVIEW = 778
  • SAMPLE RANGE ACROSS STUDIES = 18–260 patients
  • KEY SAMPLE CHARACTERISTICS: Mixed etiologies of lymphedema and various tumor types

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

The treatments included in this study were compression stockings, coumarin, pneumatic compression devices, microsurgery, manual lymphatic drainage, and an herbal remedy combining coumarin ginkgo and melitoto. There was a high risk of bias among the studies. Various methods of measuring limb volume were used. All studies reported favorable outcomes with a reduction of limb excess volume from 6.8% to 20%. The largest effect was reported with complete decongestive therapy. Some studies included patients with lymphedema etiologies other than cancer. Only one study using each type of intervention was found.

Conclusions

The effectiveness of various treatments for lower limb lymphedema are unclear because of the very limited evidence in this area.

Limitations

  • Low-quality studies
  • Very few studies found

Nursing Implications

There is very little evidence regarding the efficacy of various interventions for lower limb lymphedema in patients with cancer. Lymphedema can be disabling, and effective interventions have not been identified. This is an area in which additional, well-designed research is needed.

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Letellier, M., Towers, A., Shimony, A., & Tidhar, D. (2014). Breast cancer-related lymphedema: A randomized controlled pilot and feasibility study. American Journal of Physical Medicine & Rehabilitation, 93, 751–763.

Study Purpose

To assess whether conducting a larger randomized, controlled trial of aqua lymphatic therapy (ALT) would be feasible and to estimate the extent to which ALT combined with home-based exercise compared with home-based exercise alone would reduce arm disability in patients with breast cancer-related lymphedema

Intervention Characteristics/Basic Study Process

Twenty-five women were randomly assigned to one of two groups, either ALT combined with home-based exercises or home-based exercises alone. Each woman was assessed before the intervention and after the 12-week intervention with pool-based therapy exercises. Arm volume, arm disability, pain, and quality of life were measured.

Sample Characteristics

  • N = 25  
  • AGE = Control group: 53.4 years (SD = 9.35 years), ALT group: 56.4 years (SD = 9.76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: In remission from stage I or II breast cancer, wearing a well-fitted compression garment, at least two months after radiation or chemotherapy, and at least six months after surgery

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: McGill University Health Center, Montreal, Quebec

Phase of Care and Clinical Applications

  • APPLICATIONS: Elder care, palliative care 

Study Design

Single-blinded, randomized, controlled pilot study

Measurement Instruments/Methods

  • Participants' arm fluid volume was measured by water displacement volumetry and circumferential measurements.
  • Grip strength was measured using a baseline hand hydraulic dynamometer.
  • Pain was assessed using the short-form McGill Pain Questionnaire (MPQ).
  • Upper extremity function was measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
  • Quality of life was assessed using the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B) version 4

Results

No reductions were found in limb volume in either group. Participants in the ALT group showed significant beneficial changes after 12 weeks of treatment, specifically on the Palliative Prognostic Index (PPI) score when compared to the control group (p = 0.025). There were no other significant improvements between groups. Within groups, there were significant improvements pre- and postintervention in healthy arm grip strength (p = .001 for both groups), affected arm grip strength (p = .008 for both groups), DASH scores (p = .016 in ALT group), FACT-B scores (p = .021 in ALT group), and PPI scores (p = .025 in ALT group).

Conclusions

A larger randomized, controlled trial would be feasible. ALT showed significant improvement in grip strength and DASH, FACT, and PPI scores after 12 weeks of ALT treatment. The intervention did not make lymphedema volume worse, and therefore it may be a safe alternative to land-based treatments of breast cancer-related lymphedema.

Limitations

  • Small sample (< 30)
  • Other limitations/explanation: Patients with open wounds would not be able to receive this intervention.

Nursing Implications

In this study, ALT showed no benefit in arm volume reduction over the control group. ALT was, however, effective at reducing pain intensity scores in the experimental group. Nurses should be aware that ALT does not appear to worsen limb volume in women with breast cancer who have been diagnosed with lymphedema, but it also does not improve limb volume. Nurses should note that ALT may be one potential intervention to help reduce the intensity of pain in breast cancer survivors with lymphedema.

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Lesser, G. J., Case, D., Stark, N., Williford, S., Giguere, J., Garino, L. A., . . . Wake Forest University Community Clinical Oncology Program Research Base. (2013). A randomized, double-blind, placebo-controlled study of oral coenzyme Q(10) to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. Journal of Supportive Oncology, 11, 31–42.

Study Purpose

To determine the effect of ​coenzyme Q10 (CoQ10) on self-reported fatigue, depression, and quality of life.

Intervention Characteristics/Basic Study Process

Patients were women with breast cancer and planned adjuvant chemotherapy randomized to oral supplements of 300 mg of CoQ10 or placebo, each combined with 300 IU of vitamin E in three daily doses. The intervention began within four days of starting chemotherapy and was continued for 24 weeks. All study assessments were conducted at baseline and 8,16, and 24 weeks. Serum CoQ10 and vitamin E levels were used to measure adherence to the study medications.

Sample Characteristics

  • The study included 175 patients with breast cancer (all women) who completed eight weeks and 139 patients who completed 24 weeks.  
  • Median age was 51 years (range 28–85).
  • Patients were newly diagnosed with breast cancer.

Setting

Patients' homes in South Carolina

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a randomized, placebo-controlled, double-blind trial.

Measurement Instruments/Methods

The study used multiple instruments with the primary outcome of fatigue:

  • Profile of Mood States-Fatigue (POMS-F)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Linear analogue scale assessment [LASA]-Fatigue.

Results

No significant differences existed between the CoQ10 and placebo arms at 24 weeks for scores on the outcome instruments measuring fatigue. In addition, no significant differences were found on secondary outcomes, such as quality of life measured by the FACT-Brease Cancer (BC) instrument or the ​Center for Epidemiologic Studies Depression (CESD) Scale measuring depression.

Conclusions

Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or quality of life after 24 weeks of treatment.

Nursing Implications

The study suggests that no evidence exists that using standard-dose CoQ10 supplementation to target fatigue in newly diagnosed women with breast cancer is effective in ameliorating treatment-related fatigue.

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Lesniak, W., Bala, M., Jaeschke, R., & Krzakowski, M. (2008). Effects of megestrol acetate in patients with cancer anorexia-cachexia syndrome—A systematic review and meta-analysis. Polskie Archiwum Medycyny Wewnetrznej, 118, 636–644.

Purpose

To assess the clinical effects of megestrol acetate (MA) on anorexia-cachexia syndrome (ACS) via systematic review and meta-analysis

Search Strategy

The MEDLINE, Embase, and Central databases were used to find research from 2002–2007. The previous systematic review by Lopez et al. (2004) was used to identify additional references. Reference lists of the studies included were also reviewed.

The search keywords used were neoplasm, cancer, cachexia, anorexia, and megestrol acetate.

Inclusion criteria were:

  • Randomization
  • Studies of advanced-stage cancer (other than hormone-dependent cancer and ACS)
  • An MA intervention compared to a placebo or other drugs
  • Clinical studies of ACS or MA
  • Study of outcomes such as survival, weight change, and performance status
  • Study of quality-of-life parameters such as appetite, nausea, pain, fatigue, depression, well-being, or mood.

Literature Evaluated

There were no language restrictions for the studies included. The review also included conference abstracts. No flowchart or additional description of initial study volume or eliminations was provided. The validity of eligible studies was assessed to ensure intent-to-treat analysis and completeness of follow-up.

Findings were presented for studies in 21 different categories. These categories were defined according to MA dose; outcomes evaluated; and whether MA was dispensed in varying doses, compared to a placebo, or compared to other drugs, with relative risk findings for effect size.

Sample Characteristics

  • The final number of included studies was 30. Five of these were abstracts.
  • All studies included patients with advanced-stage cancer.
  • In most studies, participants had a variety of cancers. In several studies, lung cancer was a criterion for inclusion; several more studies involved head and neck cancer.

Results

Pooled analysis was completed and statistical significance of overall effects was calculated via the Z-test. Homogeneity of results between studies was analyzed with the chi-square test. Results were summarized by GRADE group categorization.

MA administration is associated with appetite improvement, increased probability of weight gain, and a higher probability of delay in deterioration of performance status. The conclusions regarding MA's influence on other symptoms, quality-of-life indices, and performance status were not clear.

There appears to be a dose-response relationship for achievement of weight gain. To obtain improved appetite, it appears that a low dose of MA (160 mg) is as effective as higher doses. At this low dose, there was a beneficial trend compared to the placebo, and a significant effect of a dose increase has not been demonstrated.

The effects of MA are not significantly different than those of glucocorticosteroids. In a previous review, lower-extremity edema in short-term follow-up and potential increased risk of embolic complications in long-term follow-up were identified as adverse effects of MA

Conclusions

Results suggest that MA has a beneficial effect on appetite.
 

Limitations

  • This review included only advanced cancer cases. The role of MA earlier in the course of disease was not addressed here.
  • Studies reviewed were found to be of low quality. Due to this, additional randomized controlled trials with MA are suggested.
  • It is suggested that further study of MA's role in ACS include determination of the relative value attributed by patients to individual symptoms affected by MA's use.
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