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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2024
  • participants needed
    422
  • sponsor
    University of Rochester NCORP Research Base
Updated on 17 November 2021
cancer
bupropion

Summary

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.

Description

PRIMARY OBJECTIVES:

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.

Details
Condition Cancer Survivor, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Cancer Fatigue, Complete Remission, cancer-related fatigue
Treatment questionnaire administration, quality-of-life assessment, Placebo, Bupropion Hydrochloride Controlled-release
Clinical Study IdentifierNCT03996265
SponsorUniversity of Rochester NCORP Research Base
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

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, 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

Exclusion Criteria

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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