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
- 1
- 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
- •Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
- •≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
- •Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
- •English speaking,
- •Physician medical clearance for study participation,
- •Able to ambulate without assistance,
- •No antibiotics for the past 90 days,
- •Willing to avoid taking probiotics for the duration of the study
- •Peak VO2 <30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
排除标准
- •Metastatic or recurrent cancer
- •Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
- •Unstable angina
- •New York Heart Association class II, III, or IV congestive heart failure
- •Uncontrolled asthma
- •Interstitial lung disease
- •Current steroid use
- •Having been told by a physician to only do exercise prescribed by a physician
- •Dementia or organic brain syndrome
- •Schizophrenia or active psychosis
- •Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
- •Anticipate elective surgery during the study period
- •Anticipate changes in usual medications during the study period
- •Plan to move residence out of the local area during the study period
- •Plan to travel out of the local area for >1 week during study participation
- •Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
- •Currently pregnant or anticipate pregnancy during study participation
- •Live or work >50 miles from study site or do not have transportation to study site
- •Anticipate needing antibiotics during the study period
研究组 & 干预措施
Aerobic Exercise Training
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
干预措施: Aerobic Exercise Training (Other)
Attention Control
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
干预措施: Attention Control (Other)
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
Composition of gut microbiota as measured by fecal samples
时间窗: Baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
时间窗: 5 weeks after baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
时间窗: 10 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)
- Systemic inflammation tested via blood biomarkers(5 weeks after baseline)
- Systemic inflammation tested via blood biomarkers(Baseline)
- Concentration of cortisol measured through hair sample(10 weeks after baseline)
- Autonomic nervous system measured through non-invasive ECG(Baseline)
- Autonomic nervous system measured through non-invasive ECG(5 weeks after baseline)
- Autonomic nervous system measured through non-invasive ECG(10 weeks after baseline)
- Concentration of cortisol measured through hair sample(Baseline)
- Concentration of cortisol measured through hair sample(5 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(Baseline)
- Fatigue measured through fatigue specific questionnaire(5 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(10 weeks after baseline)
研究者
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham