title: The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study.
abstract: OBJECTIVE
  To determine the effects of thalidomide and placebo on anorexia-cachexia and its related symptoms, body composition, resting metabolic rate, and serum cytokines and their receptors in patients with advanced cancer.
  
  
  METHODS
  Included in the study were patients with advanced cancer with weight loss greater than 5% in 6 months and who reported anorexia, fatigue, and one of the following: anxiety, depression, or sleep disturbances. Patients on chemotherapy within 2 weeks prior or during the study were excluded from the study. Patients were randomly assigned to either 100 mg thalidomide or placebo once a day for 14 days. The Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Functional Assessment of Cancer Illness Therapy (FACIT-F), Hospital Anxiety Depression Scale (HADS) Pittsburgh Sleep Quality Index (PSQI) were utilized, and in addition body composition, Resting Energy Expenditure (REE), and serum cytokine levels were assessed.
  
  
  RESULTS
  Of the 31 patients entered in the study, 15 were assigned to the thalidomide group and 16 to the placebo group. However only 21/31 patients were able to complete the study. Compared with their baseline values, both the thalidomide and the placebo groups showed significant reduction in cytokines. Tumor necrosis factor (TNF)-α (p=0.04) and its receptors TNFR1 (p=0.04), TNFR2 (p=0.04), and interleukin (IL)-8 (p=0.04) were statistically significant in the thalidomide group. In the placebo group, TNF-α (p=0.008), TNFR1 (p=0.005), TNFR2 (p=0.005), IL-RA (p=0.005), IL-6 (p=0.005), and IL-8 (p=0.005) were statistically significant. However, improvement in these symptoms and cytokine levels were not significantly different in the thalidomide group compared with the placebo group. None of the patients withdrew from the study because of toxicity of either thalidomide or placebo.
  
  
  CONCLUSIONS
  Based on the poor accrual rate and attrition observed in this study, it is important that future research on thalidomide as a treatment for cancer-related anorexia-cachexia symptoms (ACS) in patients with advanced cancer use less stringent entry criteria and less exhaustive outcome measures.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA. syennu@mdanderson.org
authors.forename: Sriram
authors.initials: S
authors.lastname: Yennurajalingam
authors.forename: Jie S
authors.initials: JS
authors.lastname: Willey
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Julio
authors.initials: J
authors.lastname: Allo
authors.forename: Egidio
authors.initials: E
authors.lastname: Del Fabbro
authors.forename: Evan N
authors.initials: EN
authors.lastname: Cohen
authors.forename: Sanda
authors.initials: S
authors.lastname: Tin
authors.forename: James M
authors.initials: JM
authors.lastname: Reuben
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000473:pathology; D013781:Texas; D013792:Thalidomide / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D013792:Thalidomide