title: A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.
abstract: OBJECTIVE
  Fatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. We investigated whether armodafinil could reduce cancer-related fatigue in MM patients.
  
  
  METHODS
  This double-blind, placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue. Patients were randomized to one of two arms: treatment-only, with armodafinil given at 150 mg/daily for 56 days, or placebo-first, with placebo given on days 1-28, followed by armodafinil administered at 150 mg daily on days 29-56. Fatigue was measured on days 1 (pre-dose: baseline), 15, 28, 43, and 56 using seven separate assessments, including four patient-reported outcomes of fatigue and related quality of life measures, as well as three objective measures of cognitive function.
  
  
  RESULTS
  Overall toxicities were similar between treatment groups. No significant differences were observed between the placebo-first and the treatment-only arms after 28 days. Treatment with armodafinil for 28 additional days did not produce responses. Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline. Placebo-first patients improved on eight additional measures (one patient-reported measure, six subscales, and one objective task), suggesting a strong placebo effect in this patient population.
  
  
  CONCLUSIONS
  Evaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.
authors.affiliation: Oncotherapeutics, West Hollywood, CA, USA, jberenson@imbcr.org.
authors.forename: James R
authors.initials: JR
authors.lastname: Berenson
authors.forename: Ori
authors.initials: O
authors.lastname: Yellin
authors.forename: Hesaraghatta K
authors.initials: HK
authors.lastname: Shamasunder
authors.forename: Chien-Shing
authors.initials: CS
authors.lastname: Chen
authors.forename: Veena
authors.initials: V
authors.lastname: Charu
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Woliver
authors.forename: Shamel
authors.initials: S
authors.lastname: Sanani
authors.forename: Michael
authors.initials: M
authors.lastname: Schlutz
authors.forename: Youram
authors.initials: Y
authors.lastname: Nassir
authors.forename: Regina A
authors.initials: RA
authors.lastname: Swift
authors.forename: Claudia
authors.initials: C
authors.lastname: Andreu-Vieyra
authors.forename: Robert
authors.initials: R
authors.lastname: Vescio
mesh_terms: D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009101:Multiple Myeloma / Q000150:complications* / Q000188:drug therapy; D015990:Placebo Effect; D011788:Quality of Life; D014851:Wakefulness / Q000187:drug effects; D064690:Wakefulness-Promoting Agents / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil