Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors

University of Rochester NCORP Research Base

Status and phase: Active, not recruiting; Phase 3

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Questionnaire Administration; Drug: Bupropion Hydrochloride Controlled-release; Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection; Other: Placebo Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03996265

UG1CA189961 (U.S. NIH Grant/Contract)

URCC-18007 (Other Identifier)

R01CA214647 (U.S. NIH Grant/Contract)

NCI-2019-01528 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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422 participants in 2 patient groups, including a placebo group

Arm I (bupropion hydrochloride controlled-release)

Experimental group

Description:

Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study.

Treatment:

Procedure: Biospecimen Collection

Other: Quality-of-Life Assessment

Drug: Bupropion Hydrochloride Controlled-release

Other: Questionnaire Administration

Arm II (placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Administration

Procedure: Biospecimen Collection

Other: Quality-of-Life Assessment

Other: Questionnaire Administration