The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.
详细描述
The investigators will conduct a pilot randomized-controlled, crossover trial to evaluate the feasibility, acceptability and effect of the open-label administration of placebo pills on CRF and associated psychosocial factors (e.g., emotional health, social health, quality of life, etc.) for cancer survivors (CSs) who have completed all cancer treatments yet continue to experience CRF. Additionally, in an exploratory manner, the investigators will collect DNA saliva specimens that will be analyzed for potential biomarkers that may predict placebo responses. To do this, investigators will use a 7-week, single site, two-parallel arm, randomized controlled crossover pilot study to determine the feasibility, acceptability and effects of an Open Label Placebo Intervention (OLPI) on CSs who completed cancer treatments at least 6 months prior to enrollment in the study and report a fatigue score of 4 or greater on a 0-10 scale. Investigators will enroll 80 eligible CS participants who will be randomized into two groups of 40 (Group1 and Group2 ). In this crossover study, participants in Group1, will receive an OLP (placebo pill) for 21-days (Period 1)and Group2 (Observational Controls) will not. After a 1-week washout period, Group2 will receive the OLP for 21-days (Period 2) and Group1 (Observational Controls) will not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Stage II - IV cancer;
- •Completed primary treatment 6months to 10 years;
- •Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale;
- •Agree not to change any medications or treatments during the study;
- •Willingness to make 4 clinical site visits over the course of the 49-day study.
排除标准
- •Stage 1 cancer;
- •Uncontrolled diabetes;
- •Uncontrolled COPD;
- •Uncontrolled ischemic heart disease;
- •Uncontrolled liver/kidney diseases;
- •Uncontrolled autoimmune diseases;
- •Uncontrolled psychiatric or cognitive diseases.
结局指标
主要结局
Enrollment Rate
时间窗: End of Study (7 weeks)
Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
Accrual Rate as a Measure of Feasibility
时间窗: End of Study (7 weeks)
Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
Adherence Rate as a Measure of Feasibility
时间窗: End of Study (7 weeks)
Unit of measure: number of placebos taken / number prescribed (84)
Retention as a measure of Acceptability
时间窗: End of Study (7 weeks)
Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled
Eligibility as a measure of Feasibility
时间窗: End of Study (7 weeks)
Unit of measure: number eligible for enrollment / number screened
次要结局
- Measure of fatigue manifestation(Baseline, 3 weeks, 4 weeks and 7 weeks)
- Measurement of impact of fatigue on quality of life(Baseline, 3 weeks, 4 weeks and 7 weeks)
- Measurement of fatigue severity(Baseline, 3 weeks, 4 weeks and 7 weeks)
- Measurement of the impact of fatigue on physical function(Baseline, 3 weeks, 4 weeks and 7 weeks)
研究者
Theresa W. Hoenemeyer
Director, Education and Support Services, Comprehensive Cancer Center
University of Alabama at Birmingham