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Using bupropion to alleviate fatigue in cancer survivors

Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue

PHASE3 · University of Rochester · NCT03996265

This study is testing if the medication bupropion can help cancer survivors feel less tired and improve their overall quality of life.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment422 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Rochester (other)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations542 sites (Anchorage, Alaska and 541 other locations)
Trial IDNCT03996265 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates the effectiveness of bupropion hydrochloride in reducing cancer-related fatigue among cancer survivors. The study employs a double-blinded, placebo-controlled, randomized design, where participants are assigned to receive either bupropion or a placebo for up to 13 weeks. The primary objective is to assess the reduction of fatigue levels, while secondary objectives include evaluating the impact on depression and quality of life. Additionally, the study will explore the tolerability of bupropion and its effects on cognitive function and underlying mechanisms of fatigue.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with cancer and report moderate to severe fatigue.

Not a fit: Patients currently undergoing active cancer treatment or those with mild fatigue may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for cancer survivors suffering from fatigue.

How similar studies have performed: Other studies have shown promise in using bupropion for fatigue management, but this specific application in cancer survivors is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Anchorage, Alaska and 541 other locations

+492 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.