Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT03996265
Trial Phases:	Phase III	Protocol IDs:	URCC-18007 (primary) URCC-18007 URCC-18007 NCI-2019-01528
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	University of Rochester NCORP Research Base
NCI Full Details:	http://clinicaltrials.gov/show/NCT03996265

Summary

This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. It belongs to the family of drugs called antidepressants and works by increasing certain types of activity in the brain. Bupropion may reduce cancer-related fatigue by causing changes in inflammation and stress hormones. Giving bupropion may improve cancer related fatigue in cancer survivors.

Objectives

PRIMARY OBJECTIVE:
I. To determine the efficacy of bupropion hydrochloride controlled-release (bupropion) versus placebo in reducing fatigue in a double-blinded, placebo-controlled, randomized clinical trial of cancer survivors with fatigue.

SECONDARY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on depression and quality of life in cancer survivors with fatigue.
II. To assess the tolerability of bupropion in cancer survivors with fatigue.

EXPLORATORY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on symptomatology and cognition in cancer survivors with fatigue.
II. To explore the effects of bupropion on putative mechanisms of cancer-related fatigue.
III. To explore associations of CYP2B6 genotype with bupropion metabolism and changes in fatigue.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive bupropion hydrochloride controlled-release orally (PO) once daily (QD) for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.

ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.