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Antidepressant

Bupropion for Fatigue in Breast Cancer Survivors

Phase 3
Recruiting
Led By Heather S Jim
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 a diagnosis of stage I-III breast cancer
Must not have
Be receiving intravenous anti-cancer therapy (e.g., intravenous immune checkpoint inhibitor therapy, targeted therapy)
Have a history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial will study how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Bupropion may cause side effects such as headaches, dry mouth, nausea, difficulty sleeping (insomnia), and increased blood pressure. Some people might experience anxiety or agitation. It's important for participants with allergies to lactose to note that they should avoid this trial due to potential reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have felt moderate to severe fatigue in the last week.
Select...
My breast cancer is at an early to mid-stage (I-III).
Select...
My cancer is not getting worse or is undetectable.
Select...
My worst fatigue level last week was moderate to severe.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently receiving IV treatment for cancer, such as immunotherapy or targeted therapy.
Select...
I have a history of seizures.
Select...
I am currently taking medication that contains bupropion.
Select...
I have a history of kidney problems.
Select...
I have a history of severe liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fatigue
Secondary study objectives
Depression
Quality of life (i.e., physical well-being, functional well-being, emotional well-being, and social well-being)
Other study objectives
Cognition
Symptomatology

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteOTHER
562 Previous Clinical Trials
144,426 Total Patients Enrolled
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,721 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,607 Total Patients Enrolled

Media Library

Bupropion Hydrochloride Controlled-release (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT03996265 — Phase 3
Cancer Research Study Groups: Arm II (placebo), Arm I (bupropion hydrochloride controlled-release)
Cancer Clinical Trial 2023: Bupropion Hydrochloride Controlled-release Highlights & Side Effects. Trial Name: NCT03996265 — Phase 3
Bupropion Hydrochloride Controlled-release (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03996265 — Phase 3
Cancer Patient Testimony for trial: Trial Name: NCT03996265 — Phase 3
~56 spots leftby Sep 2025
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