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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 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.
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 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
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
559 Previous Clinical Trials
144,175 Total Patients Enrolled
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,721 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,879 Previous Clinical Trials
41,012,824 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
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