NCT03996265

Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors

Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (estimated)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Bupropion Hydrochloride Controlled-release	Given PO
OTHER	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-06-27
• Primary completion: 2026-05-30
• Completion: 2026-08-05
• First posted: 2019-06-24
• Last updated: 2026-01-15

Locations

542 sites across 1 country: United States

Regulatory

• FDA-regulated drug study