Clinical trial · Interventional
Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors
Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bupropion Hydrochloride Controlled-release | Drug | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (bupropion hydrochloride controlled-release)
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Bupropion Hydrochloride Controlled-release
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available