Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors

Inclusion Criteria

• 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 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

Exclusion Criteria

• Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban)
• Be taking an monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within two 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 psychiatric or neurological disorder(s) that would interfere with study participation per physician or physician’s designee

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 breast cancer survivors with fatigue.

SECONDARY OBJECTIVES:

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.

EXPLORATORY OBJECTIVES:

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.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
University of Rochester NCORP Research Base

Principal Investigator
Heather S.L. Jim

• Primary ID URCC-18007
• Secondary IDs NCI-2019-01528
• Clinicaltrials.gov ID NCT03996265