Effectiveness Not Established

Thalidomide

for Fatigue

Thalidomide was used in the 1960s as an anxiolytic and antiemetic agent for pregnant women and was withdrawn from use because of its teratogenic effects. Because of its antiangiogenic properties, it has resurfaced as an antineoplastic drug and currently is indicated for the treatment of multiple myeloma.Thalidomide reduces the production of tumor necrosis factor alpha. It has been used in AIDS-associated cachexia and has been studied in cancer-related anorexia and cachexia. Adverse effects include dizziness, drowsiness, somnolence, constipation, and increased incidence of thromboembolic events. The use of thalidomide is strictly regulated because of its teratogenic effects. Thalidomide use has been examined in patients with cancer for treatment of anorexia, fatigue, and chemotherapy-induced nausea and vomiting.

 

Research Evidence Summaries

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.

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

  • The sample was comprised of 93 patients (59% male, 41% female).
  • Mean age was 62 years.
  • Cancer diagnoses were various tumor types with stage III or IV disease, and 62% of the patients were receiving palliative chemotherapy.

Setting

  • Single site
  • Outpatient
  • 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

  • Body weight
  • Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
  • European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORT QLQ-C30)
  • Visual analog scale (VAS) for appetite
  • Grip strength dynamometry
  • Serum levels of interleukin-6 (IL-6) or tumor necrosis factor-alpha (TNFα)
  • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

Results

  • Both groups showed improvement in appetite (p < 0.01) and body weight (p = 0.02).
  • No significant difference was found between groups in change in appetite.
  • Patients receiving both MA and thalidomide showed significant reduction in fatigue, whereas those on MA only had increased fatigue (p < 0.01). 
  • Grip strength and IL-6 improved in the patients receiving both drugs compared to those receiving only MA (p < 0.05).
  • A portion (7.8%) of the initial sample withdrew because of severe side effects, such as thromboembolism. 
  • 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

  • The sample size was small, with less than 100 patients.
  • 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.

Print