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Bupropion Hydrochloride Controlled-release for Breast Cancer

Northwest Cancer Center - Main Campus, Crown Point, IN
Breast Cancer+22 More ConditionsBupropion Hydrochloride Controlled-release - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage III Breast Cancer
  • Stage II Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage 1 Breast Cancer
  • Cancer Survivors
  • Complete Remission
  • Cancer-related Fatigue
  • Stage 2 Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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1
Group I (paclitaxel, nilotinib hydrochloride monohydrate)
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Quality-of-Life Assessment

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At 12 weeks

At 12 weeks
Cognition
Depression
Fatigue
Quality of life
Quality of life (i.e., physical well-being, functional well-being, emotional well-being, and social well-being)
Symptomatology

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Probiotic
1
Group I (paclitaxel, nilotinib hydrochloride monohydrate)
2
Quality-of-Life Assessment

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Arm I (bupropion hydrochloride controlled-release)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

422 Total Participants · 2 Treatment Groups

Primary Treatment: Bupropion Hydrochloride Controlled-release · Has Placebo Group · Phase 3

Arm I (bupropion hydrochloride controlled-release)Experimental Group · 3 Interventions: Bupropion Hydrochloride Controlled-release, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Other, Other
Arm II (placebo)PlaceboComparator Group · 4 Interventions: Placebo Administration, Placebo, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Other, Other, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 weeks

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,306 Total Patients Enrolled
931 Trials studying Breast Cancer
1,537,986 Patients Enrolled for Breast Cancer
H. Lee Moffitt Cancer Center and Research InstituteOTHER
514 Previous Clinical Trials
127,854 Total Patients Enrolled
40 Trials studying Breast Cancer
5,728 Patients Enrolled for Breast Cancer
University of Rochester NCORP Research BaseLead Sponsor
12 Previous Clinical Trials
8,609 Total Patients Enrolled
1 Trials studying Breast Cancer
1,432 Patients Enrolled for Breast Cancer
Heather S JimPrincipal InvestigatorUniversity of Rochester NCORP Research Base

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced moderate to severe fatigue in the past week, which means you rated your fatigue as at least 4 out of 10 on a scale.

Who else is applying?

What state do they live in?
Michigan50.0%
Kansas50.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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