Yennurajalingam, S., Willey, J.S., Palmer, J.L., Allo, J., Del Fabbro, E., Cohen, E.N., . . . Bruera, E. (2012). The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: Results of a double-blind placebo-controlled randomized study. Journal of Palliative Medicine, 15, 1059–1064.

DOI Link

Study Purpose

To determine the effects of thalidomide on anorexia-cachexia and related symptoms

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either 100 mg of thalidomide or placebo orally for 14 days. Pre- and post-study measurements were done.

Sample Characteristics

  • A total of 21 patients completed the study.
  • Median patient age was 60 years, with a range of 24–81 years.
  • The sample was 59% male and 41% female.
  • Patients had multiple tumor types.
  • All patients had at least 5% weight loss in the past six months. All had to have anorexia and fatigue and at least one of the following symptoms within the preceding 24 hours: anxiety, depression, or sleep disturbance.
  • The sample was mostly Caucasian; 15% was African American and 9% was Hispanic.

Setting

The study was conducted at a single site in an outpatient setting in Anderson, TX.

Phase of Care and Clinical Applications

The study has clinical applicability for late effects and survivorship.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale
  • Functional Assessment of Anorexia/Cachexia Therapy
  • Hospital Anxiety and Depression Scale
  • Pittsburgh Sleep Quality Index
  • Bioelectrical impedance
  • Cytokine levels

Results

There was no significant change in appetite with thalidomide. Those receiving placebo had improvement in appetite at day 15 (p = 0.01). Body composition measures showed significant decline in body fat percent, fat mass, and fat-free mass by day 15 (p < 0.05), which reversed by day 29.

Conclusions

The study did not demonstrate any benefit of thalidomide for anorexia or related symptoms.

Limitations

  • The study had a small sample size, with less than 30 participants.
  • Findings are not generalizable.
  • Protocol fidelity was questionable. 
  • Participant withdrawals were 10% or greater.
  • The authors noted an approximate 30% drop-out rate and poor compliance of study participants.
  • Sample inclusion criteria were very restrictive.

Nursing Implications

This study does not provide any conclusive findings due to the small sample size and other study limitations cited.