Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- number of patients with variant allele frequency (VAF)
研究概览
简要总结
This study is being done to answer the following question: Will aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) change the biomarkers (signs of disease) found in the blood?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
For cohort 3 only. Men with histologically-confirmed localized prostate cancer undergoing active surveillance. Both patients and investigators will be fully blinded to the ctDNA status of patients during study participation.
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
- •Cohort 1: CH
- •CH called by MSK practices as documented by an MSK physician
- •Age ≥18 yrs
- •Completion of all anticancer therapy
- •High risk of cardiovascular disease defined by presence of at least one of the following:
- •Prior treatment with chemotherapy
- •Prior left-sided breast and/or chest wall radiotherapy
- •Currently receiving or previously received androgen deprivation therapy Prior bone marrow transplant
- •History of smoking
- •Currently treated for one or more cardiovascular risk factors (i.e., hypertension, diabetes, hyperlipidemia)
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cohort 2: Solid Tumor
- •Patients at risk of harboring circulating tumor DNA as defined by one of the following:
- •Histologically confirmed stage III (i.e., high risk of recurrence) colorectal cancer within 2 years of completion of all adjuvant therapy.
- •Histologically confirmed stage III breast cancer with residual disease after neoadjuvant therapy and within 12 months of completing (neo)adjuvant chemotherapy
- •Patients with metastatic breast cancer and radiographic stable disease or NED for ≥6 months and not currently receiving chemotherapy (endocrine therapy and anti-HER2 antibodies allowed)
- •Age ≥ 18 yrs
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cohort 3: Active Surveillance
- •Men with histologically confirmed localized prostate cancer undergoing active surveillance
- •Age ≥ 18 yrs
- •Performing less than 15 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cleared for exercise participation as per pre-screening clearance via PAR-Q+
- •Cohort 4: Lynch Syndrome
- •Age ≥18 yrs
- •Hereditary colorectal cancer syndrome, specifically Lynch syndrome, defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
- •Have a portion of the distal colon or rectosigmoid intact to enable collection of normal mucosa biopsies
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cleared for exercise participation as per pre-screening clearance via PAR-Q+
- •Cohort 5: EDD Phase 0a
- •Age ≥18 yrs
- •Receiving investigational agent under an EDD protocol for at least 2 months.
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cleared for exercise participation as per pre-screening clearance via PAR-Q+
- •Age ≥18 yrs
- •Newly Within 3 months of initiating investigational agent on an EDD Service protocol
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
- •Willingness to comply with all study-related procedures
- •Cleared for exercise participation as per pre-screening clearance via PAR-Q+
排除标准
- •Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed)
- •Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes (does not apply to Cohort 5: EDD)
- •Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
- •Mental impairment leading to inability to cooperate
- •Any of the following contraindications to cardiopulmonary exercise testing (Cohorts 1 and 2 only):
- •Acute myocardial infarction within 3-5 days of any planned study procedures;
- •Unstable angina
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled heart failure
- •Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- •Thrombosis of lower extremities within 3 months of any planned study procedures
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Respiratory failure
- •Acute non-cardiopulmonary disorders that may affect exercise performance
- •Room air desaturation at rest ≤ 85% (Cohorts 1 and 2 only)
研究组 & 干预措施
Individuals enrolled on Early Drug Development (EDD) trials
Participants will receive structured exercise therapy for 24 weeks. Participants will be followed by standard of care clinical follow-up
干预措施: exercise (walking) (Behavioral)
patients with clonal hematopoiesis
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: exercise (walking) (Behavioral)
Individuals with Lynch Syndrome
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: exercise (walking) (Behavioral)
Individuals with Lynch Syndrome
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: plasma samples (Other)
Individuals with Lynch Syndrome
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: blood draw (Other)
patients with clonal hematopoiesis
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: blood draw (Other)
post treatment patients with breast or colorectal cancer
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: exercise (walking) (Behavioral)
post treatment patients with breast or colorectal cancer
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: plasma samples (Other)
post treatment patients with breast or colorectal cancer
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: blood draw (Other)
men with localized prostate cancer undergoing active surveillance
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: exercise (walking) (Behavioral)
men with localized prostate cancer undergoing active surveillance
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: plasma samples (Other)
men with localized prostate cancer undergoing active surveillance
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
干预措施: blood draw (Other)
结局指标
主要结局
number of patients with variant allele frequency (VAF)
时间窗: 2 years
measured by targeted CH panel in peripheral blood
changes in residual tumor burden (Solid tumor group)
时间窗: 2 years
measured by the amount of circulating tumor DNA (ctDNA)
次要结局
未报告次要终点