Cancer
URCC-18007: Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Description
This study is a randomized, double-blind, placebo-controlled trial. Data will be analyzed using intent-to-treat principles. Statistical significance will be evaluated at the 0.05 significance level. SAS, Mplus and R will be used for analyses as appropriate.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Inclusion Criteria
Participants must:
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 be 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.
Start Date
Tuesday, October 29, 2024
Principal / Contact Name
Sarah E. Gill, MD