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

• Status: Recruiting
• Trial end date: 2024-03-24
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Morrow; University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bupropion

Criteria

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