~28 spots leftby Sep 2025

Bupropion for Fatigue in Breast Cancer Survivors

Recruiting in Palo Alto (17 mi)
+472 other locations
HS
Overseen byHeather S Jim
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Rochester NCORP Research Base
Must not be taking: Bupropion, MAOIs, Antipsychotics, others
Disqualifiers: Renal impairment, Cirrhosis, Seizures, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 Jurisdictions

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?

Bupropion, known by various names like Wellbutrin and Zyban, has been used safely in humans for conditions like depression and smoking cessation. Common side effects include dry mouth, insomnia (trouble sleeping), and dizziness, but it is generally considered safe when prescribed by a doctor.12345

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

HS

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

I have felt moderate to severe fatigue in the last week.
I finished my cancer treatment 2 months ago but may still be on oral or supportive therapy.
My breast cancer is at an early to mid-stage (I-III).
See 8 more

Exclusion Criteria

I am currently receiving IV treatment for cancer, such as immunotherapy or targeted therapy.
I have a history of seizures.
You have a history of bulimia or anorexia nervosa.
See 8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bupropion hydrochloride controlled-release or placebo orally once daily for up to 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bupropion Hydrochloride Controlled-release (Antidepressant)
Trial OverviewThe study is testing if Bupropion Hydrochloride Controlled-release can reduce fatigue in breast cancer survivors compared to a placebo (a substance with no active drug). Participants will also complete quality-of-life assessments and questionnaires to measure the impact on their fatigue levels.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (bupropion hydrochloride controlled-release)Experimental Treatment3 Interventions
Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo)Placebo Group3 Interventions
Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.

Bupropion Hydrochloride Controlled-release is already approved in Canada, Japan, Switzerland for the following indications:

🇨🇦
Approved in Canada as Wellbutrin XL for:
  • Major depressive disorder
  • Seasonal affective disorder
🇯🇵
Approved in Japan as Bupropion for:
  • Depression
🇨🇭
Approved in Switzerland as Wellbutrin SR for:
  • Major depressive disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials
14
Recruited
9,100+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials
576
Recruited
145,000+
Patrick Hwu profile image

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 profile image

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Severe fatigue affects about 25% of breast cancer survivors, and this fatigue is negatively correlated with quality of life factors such as general well-being, functioning, and mental health, supported by moderate to strong evidence from 57 studies.
Psychological interventions targeting fatigue in breast cancer survivors should focus on addressing emotional problems, sleep disturbances, physical activity, pain, coping strategies, and social support, as these factors have moderate to strong evidence linking them to fatigue levels.
The relationship of fatigue in breast cancer survivors with quality of life and factors to address in psychological interventions: A systematic review.Abrahams, HJG., Gielissen, MFM., Verhagen, CAHHVM., et al.[2019]
In a study of 68 long-term breast cancer survivors, 34% reported poor to moderate attention function, highlighting a significant incidence of attentional fatigue among this group.
Sleep disturbance was found to significantly predict attentional fatigue, explaining 16% of the variance, suggesting that addressing sleep issues could help improve attention in breast cancer survivors.
Incidence and Factors Associated With Attentional Fatigue in Working Long-term Breast Cancer Survivors.Crouch, A., Von Ah, D.[2018]
This study aims to evaluate a behavioral intervention designed to reduce fatigue in women undergoing radiotherapy for early breast cancer, addressing a significant side effect experienced by about 40% of patients.
The trial will involve 70 women, with assessments at multiple points during and after treatment to measure the feasibility of the intervention and gather insights on participants' experiences, which will help refine future studies.
ACTIVE - a randomised feasibility trial study protocol of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer: study protocol.Courtier, N., Gaze, S., Armes, J., et al.[2022]

References

The relationship of fatigue in breast cancer survivors with quality of life and factors to address in psychological interventions: A systematic review. [2019]
Incidence and Factors Associated With Attentional Fatigue in Working Long-term Breast Cancer Survivors. [2018]
ACTIVE - a randomised feasibility trial study protocol of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer: study protocol. [2022]
Factors associated with cancer-related fatigue in breast cancer patients undergoing endocrine therapy in an urban setting: a cross-sectional study. [2021]
Effect of the solution-focused brief therapy on cancer-related fatigue in breast cancer patients under adjuvant chemotherapy: a randomized trial. [2022]
Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study [2018]
Bupropion sustained release treatment reduces fatigue in cancer patients. [2017]
Cancer and Non-cancer Fatigue Treated With Bupropion: A Systematic Review. [2023]
An open-label study of the effects of bupropion SR on fatigue, depression and quality of life of mixed-site cancer patients and their partners. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. [2021]