Active, currently enrolling
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
NCT No.: NCT03996265
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Purpose
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.
Detailed Description
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
Sponsors
- University of Rochester NCORP Research Base
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