Bruera, E., Neumann, C.M., Pituskin, E., Calder, K., Ball, G., & Hanson, J. (1999). Thalidomide in patients with cachexia due to terminal cancer: Preliminary report. Annals of Oncology, 10, 857–859.

Patients received 100 mg of thalidomide by mouth at night for 10 days. If improvement was shown, patients could continue.

• A total of 72 patients entered the study; 37 were evaluable.
• Patients were eligible for study if they
  • Had metastatic cancer
  • Were not receiving antineoplastic therapy
  • Experienced weight loss of more than 5% of usual weight
  • Had a life expectancy of more than two weeks
  • Had normal cognition
  • Were postmenopausal or had no possibility of becoming pregnant; men could not have sexual activity with women who could become pregnant.

This was an open-label study.

• Visual analog scale measuring
  • Difficulty falling asleep
  • Morning restedness
  • Insomnia
  • Nausea
  • Appetite
  • Sensation of well-being
• Caloric intake form

More than 30% improvement in symptom intensity was observed in the following parameters: difficulty falling asleep (17/35 = 49%), morning restedness (23/36 = 64%), insomnia (22/32 = 69%), nausea (16/36 = 44%), appetite (22/35 = 63%), and well-being (18/34 = 53%). Twenty-seven patients completed food intake forms on days 1 and 10. Caloric intake increased from 1,325 to 1,531 calories per day (p = 0.047). Three patients discontinued thalidomide because of adverse effects: dizziness (1) and drowsiness (2).

• The study had a high attrition rate and poor compliance, possibly because of survival expectations of only more than 2 weeks.
• The study was open and subject to bias.

Findings need to be confirmed in double-blind studies.