Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 422
- 试验地点
- 542
- 主要终点
- Fatigue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (bupropion hydrochloride controlled-release)
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.
干预措施: Biospecimen Collection (Procedure)
Arm I (bupropion hydrochloride controlled-release)
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.
干预措施: Bupropion Hydrochloride Controlled-release (Drug)
Arm I (bupropion hydrochloride controlled-release)
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.
干预措施: Quality-of-Life Assessment (Other)
Arm I (bupropion hydrochloride controlled-release)
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.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
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.
干预措施: Biospecimen Collection (Procedure)
Arm II (placebo)
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.
干预措施: Placebo Administration (Other)
Arm II (placebo)
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.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Fatigue
时间窗: At baseline and 12 weeks
Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue subscale (FFS). Scale scores range from 0-4; lower scores indicate greater fatigue. Will use analysis of covariance with group as the main factor and baseline FFS as a covariate.
次要结局
- Quality of life(At baseline and 12 weeks)
- Depression(At baseline and 12 weeks)
研究者
Luke Peppone
URCC Study Co-Chair
University of Rochester NCORP Research Base