Breast Cancer Clinical Trial
Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors
This phase III trial studies how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in breast cancer survivors.
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 breast cancer survivors with fatigue.
I. To assess the efficacy of bupropion versus placebo on depression and quality of life in breast cancer survivors with fatigue.
II. To assess the tolerability of bupropion in breast cancer survivors with fatigue.
I. To assess the efficacy of bupropion versus placebo on symptomatology and cognition in breast 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.
ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity.
Have a diagnosis of stage I-III breast cancer
Report worst level of fatigue in the past week as moderate to severe (i.e., a score >= 4 on a 0-10 scale, Screening Measures, question 1)
Have completed surgery, radiation, and/or chemotherapy, at least 2 or more months prior to enrollment (participants can be receiving maintenance, targeted or hormonal therapy)
Able to read and speak English
Currently not pregnant or breastfeeding. Women of child-bearing potential must agree to use adequate contraception, i.e, abstinence, IUD (intrauterine device), hormonal contraceptive (birth control pills) or barrier method (condoms) prior to study entry and for the duration of study participation
Be capable of providing written informed consent
Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban
Be taking a monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within 2 weeks prior to enrollment
Be taking any anti-psychotic medications within a week prior to enrollment
Have a history of renal impairment (i.e., glomerular filtration rate < 45)
Have a history of cirrhosis (i.e., Child-Pugh score >= 5)
Have a history of seizures
Have a history of bulimia or anorexia nervosa
Report a history of sensitivity to bupropion
Report an allergy to lactose
Have a psychiatric or neurological disorder that would interfere with study participation per physician or physician's designee
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