Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Composition of gut microbiota as measured by fecal samples
研究概览
简要总结
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.
详细描述
Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.
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
- Single (Outcomes Assessor)
盲法说明
Assessors will be blinded to participant study group allocation
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composition of gut microbiota as measured by fecal samples
时间窗: 15 weeks after baseline
Using standard diversity and taxa comparison metrics
次要结局
- Autonomic nervous system measured through non-invasive ECG(15 weeks after baseline)
- Systemic inflammation tested via biomarkers(10 weeks after baseline)
- Systemic inflammation tested via blood biomarkers(15 weeks after baseline)
- Concentration of cortisol measured through hair sample(15 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(15 weeks after baseline)
研究者
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham