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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue
Secondary outcome measures
Depression
Quality of life (i.e., physical well-being, functional well-being, emotional well-being, and social well-being)
Other outcome measures
Cognition
Symptomatology
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
543 Previous Clinical Trials
135,060 Total Patients Enrolled
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,670 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,710 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have felt moderate to severe fatigue in the last week.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.I am currently taking medication that contains bupropion.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).I have not taken an MAOI, linezolid, or methylene blue in the last two weeks.You are allergic to lactose.I finished my surgery, radiation, or chemotherapy over 2 months ago.My cancer is not getting worse or is undetectable.My worst fatigue level last week was moderate to severe.I am 18 years old or older.I have a history of kidney problems.I have been diagnosed with cancer.I have not taken any anti-psychotic medications in the last week.I have a history of severe liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (placebo)
- Group 2: Arm I (bupropion hydrochloride controlled-release)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cancer Patient Testimony for trial: Trial Name: NCT03996265 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Bupropion Hydrochloride Controlled-release available to patients with a prescription?
"Bupropion Hydrochloride Controlled-release is a Phase 3 trial medication, meaning that it has undergone multiple rounds of clinical testing to confirm its safety. Our team has given it a 3 rating."
Answered by AI
How many individuals can take part in this research project?
"Yes, this is an ongoing study that is actively recruiting patients. The trial was posted on 06/28/2019 and was updated on 05/17/2022. They are looking for 422 patients from 100 different sites."
Answered by AI
What is Bupropion Hydrochloride Controlled-release's most popular purpose?
"Bupropion Hydrochloride Controlled-release is commonly used to treat seasonal affective disorder, however it can also be effective for other disorders like smoking cessation and smoke-related diseases."
Answered by AI
Are there any other ongoing investigations about Bupropion Hydrochloride Controlled-release?
"The first study into Bupropion Hydrochloride Controlled-release was completed in 2017 at Yale School of Medicine. As of now, a total of 18,643 clinical trials have been completed. Right now, there are 35 clinical trials that are still recruiting patients, with a high concentration in East Stroudsburg, Minnesota."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Kansas
North Carolina
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Gulf South MU-NCORP
Kaiser Permanente-South San Francisco
Rush - Copley Medical Center
Other
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m not ready to accept that this is my new normal. I’d like to think that I could get back to where I was pre cancer.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- CaroMont Regional Medical Center: < 48 hours
Typically responds via
Phone Call
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