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NCT04589468 | RECRUITING | Breast Cancer

Researching the Effect of Exercise on Cancer
Sponsor:

Memorial Sloan Kettering Cancer Center

Brief Summary:

Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.

Condition or disease

Breast Cancer

Prostate Cancer

Colorectal Cancer

Stage I Breast Cancer

Stage II Breast Cancer

Stage III Breast Cancer

Stage I Prostate Cancer

Stage II Prostate Cancer

Stage III Prostate Cancer

Stage I Colorectal Cancer

Stage II Colorectal Cancer

Stage III Colorectal Cancer

Intervention/treatment

Exercise

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Actual Study Start Date : 2020-10-02
Estimated Primary Completion Date : 2025-10-02
Estimated Study Completion Date : 2025-10-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following
    • ° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)
    • * Stage 3 or
    • * ctDNA positive
    • ° High-risk breast cancer
    • * Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
    • * Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
    • * CPS-EG score ≥ 3,
    • * CPS-EG score ≥2 w ith ypN+, or
    • * Recurrence score ≥ 25
    • * No evidence of disease
    • * Age ≥ 18
    • * Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy
    • * Non-exercising (i.e., \< 30 minutes of moderate and \< 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)
    • ° If ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.
    • * Cleared for exercise participation as per screening clearance via PAR-Q+
    • * Willingness to comply with all study-related procedures
    Exclusion Criteria
    • * Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
    • * Any other current diagnosis of invasive cancer of any kind
    • * Distant metastatic malignancy of any kind
    • * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Researching the Effect of Exercise on Cancer

Location Details

NCT04589468

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

Natera, Inc. (Data or Specimen Analysis Only)

San Carlos, California, United States, 94070

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553