Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue (URCC 18007)

Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors

Overview

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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Been diagnosed with stage I-III breast cancer
  • Be currently breast cancer-free
  • Report moderate to severe fatigue in the past week (i.e., a score >= 4 on a 0-10 scale, Screening Measures, question 1)
  • Attribute their fatigue to cancer and/or its treatment (Screening Measures, question 2)
  • Have completed surgery, radiation, standard dose chemotherapy, and/or targeted therapy 12-60 months previously (participants can be receiving hormonal therapy ? i.e., tamoxifen, anastrozole, letrozole, exemestane)
  • Able to read and speak English
  • 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

Key Exclusion Criteria

A patient may not be eligible for this study if the following criteria apply.

  • Have another medical condition in which fatigue is a prominent symptom as documented in the medical chart (e.g., anemia, autoimmune disease, sleep apnea)
  • Be currently taking bupropion, Wellbutrin, Forfivo, Aplenzin, or Zyban (i.e., bupropion prescribed for other indications); an anti-depressant including but not limited to an monoamine oxidase inhibitor (MAOI), anti-psychotic, a systemic anti-TNF agent, linezolid, methylene blue, or a systemic corticosteroid (patients who have previously completed treatment with these agents at least one week prior and meet all other eligibility criteria are eligible to participate). Participants should be off an MAOI for at least 2 weeks prior to study entry
  • 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 (e.g., schizophrenia, alcohol use disorder) as documented in the medical chart or in the judgment of the provider or study staff
  • Be currently pregnant or breastfeeding or plan to become pregnant in the next four months, due to unknown teratogenicity of bupropion

Learn More

To learn more, visit ClinicalTrials.gov

Study Type

Phase III

Sponsor(s)

Gary Morrow