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A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma

A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with... PurposeFatigue 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.MethodsThis 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.ResultsOverall 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.ConclusionsEvaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Supportive Care in Cancer Springer Journals

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References (55)

Publisher
Springer Journals
Copyright
Copyright © Springer-Verlag Berlin Heidelberg 2014
Subject
Medicine & Public Health; Oncology; Nursing; Nursing Management/Nursing Research; Pain Medicine; Rehabilitation Medicine
ISSN
0941-4355
eISSN
1433-7339
DOI
10.1007/s00520-014-2486-7
pmid
25370889
Publisher site
See Article on Publisher Site

Abstract

PurposeFatigue 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.MethodsThis 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.ResultsOverall 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.ConclusionsEvaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.

Journal

Supportive Care in CancerSpringer Journals

Published: Jun 1, 2015

Keywords: Cancer-related fatigue; Armodafinil; Myeloma; Phase 3; Cognitive function

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