Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. It belongs to the family of drugs called antidepressants and works by increasing certain types of activity in the brain. Bupropion may reduce cancer-related fatigue by causing changes in inflammation and stress hormones.
PRIMARY OBJECTIVE:
I. To determine the efficacy of bupropion hydrochloride controlled-release (bupropion) versus placebo in reducing fatigue in a double-blinded, placebo-controlled, randomized clinical trial of cancer survivors with fatigue.
SECONDARY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on depression and quality of life in cancer survivors with fatigue.
II. To assess the tolerability of bupropion in cancer survivors with fatigue.
EXPLORATORY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on symptomatology and cognition in cancer survivors with fatigue.
II. To explore the effects of bupropion on putative mechanisms of cancer-related fatigue.
III. To explore associations of CYP2B6 genotype with bupropion metabolism and changes in fatigue.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive bupropion hydrochloride controlled-release orally (PO) once daily (QD) for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.
ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.
Inclusion Criteria:
Exclusion Criteria:
Burbank, California 91505, United States
Covington, Louisiana 70433, United States
Slidell, Louisiana 70458, United States
Brighton, Michigan 48114, United States
Chelsea, Michigan 48118, United States
East China, Michigan 48054, United States
Grand Rapids, Michigan 49503, United States
Grand Rapids, Michigan 49503, United States
Norton Shores, Michigan 49444, United States
Saint Joseph, Michigan 49085, United States
Saint Joseph, Michigan 49085, United States
West Branch, Michigan 48661, United States
Ypsilanti, Michigan 48197, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Stateville, North Carolina 28625, United States
Wpafb, Ohio 45433, United States
Yakima, Washington 98902, United States
Milwaukee, Wisconsin 53210, United States
Stevens Point, Wisconsin 54482, United States
Sturgeon Bay, Wisconsin 54235-1495, United States