1. A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.
- Author
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Jim HSL, Hoogland AI, Han HS, Culakova E, Heckler C, Janelsins M, Williams GC, Bower J, Cole S, Desta Z, Babilonia MB, Morrow G, and Peppone L
- Subjects
- Age Factors, Antidepressive Agents, Second-Generation administration & dosage, Antidepressive Agents, Second-Generation adverse effects, Antidepressive Agents, Second-Generation pharmacokinetics, Bupropion administration & dosage, Bupropion adverse effects, Bupropion pharmacokinetics, Cytochrome P-450 CYP2B6 genetics, Delayed-Action Preparations, Depression etiology, Double-Blind Method, Fatigue genetics, Female, Health Behavior, Humans, Menopause, Quality of Life, Research Design, Socioeconomic Factors, Vinca Alkaloids, Randomized Controlled Trials as Topic, Antidepressive Agents, Second-Generation therapeutic use, Breast Neoplasms complications, Bupropion therapeutic use, Cancer Survivors, Fatigue drug therapy, Fatigue etiology
- 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., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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