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.
RCT Entities:
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.
Authors: D M Hann; P B Jacobsen; L M Azzarello; S C Martin; S L Curran; K K Fields; H Greenberg; G Lyman Journal: Qual Life Res Date: 1998-05 Impact factor: 4.147
Authors: Eduardo Bruera; Sriram Yennurajalingam; J Lynn Palmer; Pedro E Perez-Cruz; Susan Frisbee-Hume; Julio A Allo; Janet L Williams; Marlene Z Cohen Journal: J Clin Oncol Date: 2013-05-20 Impact factor: 44.544
Authors: Martin R Stockler; Rachel O'Connell; Anna K Nowak; David Goldstein; Jane Turner; Nicholas R C Wilcken; David Wyld; Ehtesham A Abdi; Amanda Glasgow; Philip J Beale; Michael Jefford; Haryana Dhillon; Stephane Heritier; Candace Carter; Ian B Hickie; R John Simes Journal: Lancet Oncol Date: 2007-07 Impact factor: 41.316
Authors: Alix G Sleight; Sylvia L Crowder; Jacek Skarbinski; Paul Coen; Nathan H Parker; Aasha I Hoogland; Brian D Gonzalez; Mary C Playdon; Steven Cole; Jennifer Ose; Yuichi Murayama; Erin M Siegel; Jane C Figueiredo; Heather S L Jim Journal: Cancers (Basel) Date: 2022-04-14 Impact factor: 6.575