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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
422
Fatigue
Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue subscale (FFS). Scale scores range from 0-4; lower scores indicate greater fatigue. Will use analysis of covariance with group as the main factor and baseline FFS as a covariate.
Time frame: At baseline and 12 weeks
Quality of life
Measured by the Total Score of the Functional Assessment Cancer Therapy - General (FACT-G) scale (included in the FACIT-F). The FACT-G consists of four subscales: physical well-being, functional well-being), emotional well-being, and social well-being. Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. This will be utilized to estimate the indirect (mediation) and direct effects and to obtain bootstrap-based 95% confidence intervals for these effects.
Time frame: At baseline and 12 weeks
Depression
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8a. Will perform mediation analyses.
Time frame: At baseline and 12 weeks
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