Bupropion for Fatigue in Breast Cancer Survivors
Trial Summary
What is the purpose of this trial?
This phase III trial studies how well bupropion works in reducing cancer related fatigue in 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 cancer survivors.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that contain bupropion and certain other medications like MAOIs, linezolid, methylene blue, and anti-psychotic medications before joining. If you are on these, you may need to stop them for a specific period before enrolling.
Is Bupropion safe for humans?
How does the drug Bupropion differ from other treatments for fatigue in breast cancer survivors?
Bupropion is unique because it is a norepinephrine-dopamine reuptake inhibitor, which means it works by increasing certain chemicals in the brain that help improve mood and energy levels. Unlike other treatments for cancer-related fatigue, which have been disappointing, Bupropion has shown significant improvement in reducing fatigue and enhancing quality of life in cancer patients.678910
Research Team
Heather S Jim
Principal Investigator
University of Rochester NCORP Research Base
Eligibility Criteria
This trial is for stage I-III breast cancer survivors who are at least 18 years old, have finished their main treatments like surgery or chemo at least two months ago, and are not currently pregnant or breastfeeding. They must be experiencing moderate to severe fatigue and cannot have certain conditions like renal impairment, a history of seizures, eating disorders, or specific medication sensitivities.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bupropion hydrochloride controlled-release or placebo orally once daily for up to 13 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bupropion Hydrochloride Controlled-release (Antidepressant)
Bupropion Hydrochloride Controlled-release is already approved in Canada, Japan, Switzerland for the following indications:
- Major depressive disorder
- Seasonal affective disorder
- Depression
- Major depressive disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester NCORP Research Base
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Patrick Hwu
H. Lee Moffitt Cancer Center and Research Institute
Chief Executive Officer since 2020
MD from The Medical College of Pennsylvania
Wade J. Sexton
H. Lee Moffitt Cancer Center and Research Institute
Chief Medical Officer
MD
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School