A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures

Heather S.L. Jim, Aasha I. Hoogland, Hyo Sook Han, Eva Culakova, Charles Heckler, Michelle Janelsins, Geoffrey C. Williams, Julienne Bower, Stephen Cole, Zeruesenay Desta, Margarita Bobonis Babilonia, Gary Morrow, Luke Peppone

Research output: Contribution to journalArticle

Abstract

Background: Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue. Methods: A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12–60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored. Discussion: This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.

Original languageEnglish (US)
Article number105976
JournalContemporary Clinical Trials
Volume91
DOIs
StatePublished - Apr 2020

Keywords

  • Breast cancer
  • Bupropion
  • Fatigue
  • Protocol
  • Randomized controlled trial

ASJC Scopus subject areas

  • Pharmacology (medical)

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    Jim, H. S. L., Hoogland, A. I., Han, H. S., Culakova, E., Heckler, C., Janelsins, M., Williams, G. C., Bower, J., Cole, S., Desta, Z., Babilonia, M. B., Morrow, G., & Peppone, L. (2020). A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. Contemporary Clinical Trials, 91, [105976]. https://doi.org/10.1016/j.cct.2020.105976