Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Cancer Survivor
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Complete Remission
- Cancer Fatigue
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: 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 breast cancer survivors with fatigue. SECONDARY OBJECTIVES: I. To assess the efficacy of...
PRIMARY OBJECTIVES: 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 breast cancer survivors with fatigue. SECONDARY OBJECTIVES: I. To assess the efficacy of bupropion versus placebo on depression and quality of life in breast cancer survivors with fatigue. II. To assess the tolerability of bupropion in breast cancer survivors with fatigue. EXPLORATORY OBJECTIVES: I. To assess the efficacy of bupropion versus placebo on symptomatology and cognition in breast 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. ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity.
Tracking Information
- NCT #
- NCT03996265
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Heather S Jim University of Rochester NCORP Research Base
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