Enrollment complete
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
NCT No.: NCT03996265
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: Colorado
Acronym:
Official Title
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Purpose
This phase III trial studies how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in breast cancer survivors.
Detailed 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 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.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
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• Be at least 18 years of age
• Be diagnosed with cancer
• Have stable disease or no evidence of disease
• 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 completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) 2 or more months prior to enrollment. Participants currently receiving oral maintenance, targeted, or hormonal therapy are eligible. Participants receiving intravenous supportive therapy (e.g., bisphosphonates) are eligible
• Able to read and speak English
• Currently not pregnant or breastfeeding. Women of child-bearing potential must agree to use adequate contraception, i.e, abstinence, IUD (intrauterine device), hormonal contraceptive (birth control pills) or barrier method (condoms) prior to study entry and for the duration of study participation
• Be capable of providing written informed consent
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Exclusion Criteria
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• Be receiving intravenous anti-cancer therapy (e.g., intravenous immune checkpoint inhibitor therapy, targeted therapy)
• Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban)
• Be taking an monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within two weeks prior to enrollment
• Be taking any anti-psychotic medications within a week prior to enrollment
• Have a history of renal impairment (i.e., glomerular filtration rate < 45)
• Have a history of cirrhosis (i.e., Child-Pugh score >= 5)
• Have a history of seizures
• Have a history of bulimia or anorexia nervosa
• Report a history of sensitivity to bupropion
• Report an allergy to lactose
• Have psychiatric or neurological disorder(s) that would interfere with study participation per physician or physician's designee
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Keywords and/or Specific Medical Conditions
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Antidepressive Agents, Second-Generation
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Cytochrome P-450 CYP2D6 Inhibitors
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Cytochrome P-450 Enzyme Inhibitors
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Dopamine Uptake Inhibitors
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Membrane Transport Modulators
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Molecular Mechanisms of Pharmacological Action
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Neurotransmitter Uptake Inhibitors
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Physiological Effects of Drugs
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Sponsors
- National Cancer Institute (NCI)
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- University of Rochester NCORP Research Base
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