| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Behavioral: exercise (walking) Other: plasma samples Other: blood draw | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail |
| Actual Study Start Date : | June 20, 2019 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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
|
Behavioral: exercise (walking)
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate 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
Other: blood draw fasting blood
|
|
Experimental: 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
|
Behavioral: exercise (walking)
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate 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
Other: plasma samples Plasma samples will be obtained at baseline.
Other: blood draw fasting blood
|
|
Experimental: 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
|
Behavioral: exercise (walking)
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate 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
Other: plasma samples Plasma samples will be obtained at baseline.
Other: blood draw fasting blood
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Cohort 1: CH
High risk of cardiovascular disease defined by presence of at least one of the following:
Cohort 2: Solid Tumor
Patients at risk of harboring circulating tumor DNA as defined by one of the following:
Cohort 3: Active Surveillance
Exclusion Criteria:
Any of the following contraindications to cardiopulmonary exercise testing (Cohorts 1 and 2 only):
| Contact: Lee Jones, PhD | 646 888-8103 | jonesl3@mskcc.org | |
| Contact: Jessica Scott, PhD | 646 888-8103 | scottj1@mskcc.org |
| United States, California | |
| University of California, Los Angeles (Data or Specimen Analysis Only) | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Paul C Boutros, PhD 310-794-7160 | |
| United States, Colorado | |
| SOMALOGIC (Data or Specimen Analysis Only) | Not yet recruiting |
| Boulder, Colorado, United States, 80301 | |
| Contact: Paul Boutros, PhD 303-625-9000 | |
| United States, New Jersey | |
| Memoral Sloan Kettering Monmouth | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Bergen | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| United States, New York | |
| Memorial Sloan Kettering Commack | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memoral Sloan Kettering Westchester | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Lee Jones, PhD 646-888-8103 jonesl3@mskcc.org | |
| Principal Investigator: Lee Jones, PhD | |
| Memorial Sloan Kettering Nassau | Recruiting |
| Uniondale, New York, United States, 11553 | |
| Contact: Lee Jones, PhD 646-888-8103 | |
| United States, North Carolina | |
| LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only) | Not yet recruiting |
| Burlington, North Carolina, United States, 27215 | |
| Contact: Suzanne Carlisle 336-436-5760 | |
| Duke University Medical Center (Data or Specimen Analysis Only) | Not yet recruiting |
| Durham, North Carolina, United States, 27701 | |
| Contact: Jason Locasale, PhD 919-684-9309 | |
| Principal Investigator: | Lee Jones, PhD | Memorial Sloan Kettering Cancer Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 20, 2019 | ||||||||
| First Posted Date ICMJE | June 24, 2019 | ||||||||
| Last Update Posted Date | May 27, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 20, 2019 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Researching the Effect of Aerobic Exercise on Cancer | ||||||||
| Official Title ICMJE | Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail | ||||||||
| Brief Summary | 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? | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: 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. Primary Purpose: Treatment
|
||||||||
| Condition ICMJE | Cancer | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
48 | ||||||||
| Original Estimated Enrollment ICMJE |
36 | ||||||||
| Estimated Study Completion Date ICMJE | June 2022 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Cohort 1: CH
Cohort 2: Solid Tumor
Cohort 3: Active Surveillance
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03996239 | ||||||||
| Other Study ID Numbers ICMJE | 19-126 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
| Verification Date | May 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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