Wen, H. S., Li, X., Cao, Y. Z., Zhang, C. C., Yang, F., Shi, Y. M., & Peng, L. M. (2012). Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide. Chemotherapy, 58, 461–467.
DOI Link
Study Purpose
To confirm the effectiveness of the combination of megestrol acetate (MA) and thalidomide for the treatment of cancer cachexia.
Intervention Characteristics/Basic Study Process
Patients were randomly assigned to receive either 160 mg of MA and 50 mg of thalidomide daily or MA alone for eight weeks. Study measures were obtained at baseline and eight weeks.
Sample Characteristics
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The sample was comprised of 93 patients (59% male, 41% female).
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Mean age was 62 years.
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Cancer diagnoses were various tumor types with stage III or IV disease, and 62% of the patients were receiving palliative chemotherapy.
Setting
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Single site
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Outpatient
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China
Phase of Care and Clinical Applications
The study has clinical applicability for late effects, survivorship, and palliative care.
Study Design
This was a randomized, parallel, two-group trial.
Measurement Instruments/Methods
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Body weight
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Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
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European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORT QLQ-C30)
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Visual analog scale (VAS) for appetite
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Grip strength dynamometry
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Serum levels of interleukin-6 (IL-6) or tumor necrosis factor-alpha (TNFα)
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National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
Results
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Both groups showed improvement in appetite (p < 0.01) and body weight (p = 0.02).
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No significant difference was found between groups in change in appetite.
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Patients receiving both MA and thalidomide showed significant reduction in fatigue, whereas those on MA only had increased fatigue (p < 0.01).
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Grip strength and IL-6 improved in the patients receiving both drugs compared to those receiving only MA (p < 0.05).
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A portion (7.8%) of the initial sample withdrew because of severe side effects, such as thromboembolism.
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No difference was found between groups in prevalence of adverse effects.
Conclusions
The combination of MA and thalidomide was associated with improvement in fatigue compared to those receiving only MA. The drug combination was not more effective in treating anorexia and did not show more improvement in body weight.
Limitations
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The sample size was small, with less than 100 patients.
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The study had risks of bias due to having no control group or blinding.
Nursing Implications
MA has been shown to have an effect in improving appetite in patients with cancer cachexia, but, as shown, also can have clinically significant side effects. Findings from this study did not show better results for appetite with the addition of thalidomide. This combination appeared to have a positive impact on fatigue. Nurses should be aware that patients taking MA can have side effects, such as thromboembolism, so patients receiving this treatment need to be educated and monitored for adverse events.