Jim, Heather S.L.Hoogland, Aasha I.Han, Hyo SookCulakova, EvaHeckler, CharlesJanelsins, MichelleWilliams, Geoffrey C.Bower, JulienneCole, StephenDesta, ZeruesenayBobonis Babilonia, MargaritaMorrow, GaryPeppone, Luke2022-09-152022-09-152020-04Jim HSL, Hoogland AI, Han HS, et al. A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. Contemp Clin Trials. 2020;91:105976. doi:10.1016/j.cct.2020.105976https://hdl.handle.net/1805/30011Background: 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.en-USPublisher PolicyFatigueBupropionBreast cancerRandomized controlled trialProtocolArticle