ACTIVE_NOT_RECRUITING

Researching the Effect of Exercise on Cancer

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Conditions

Breast CancerProstate CancerColorectal CancerStage I Breast CancerStage II Breast CancerStage III Breast CancerStage I Prostate CancerStage II Prostate CancerStage III Prostate CancerStage I Colorectal CancerStage II Colorectal CancerStage III Colorectal CancerexercisectDNA20-378Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer

Quick Facts

Study Start:2020-10-02
Study Completion:2025-10-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04589468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:
  2. * Stage 3 or
  3. * ctDNA positive
  4. * Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
  5. * Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
  6. * CPS-EG score ≥ 3,
  7. * CPS-EG score ≥2 w ith ypN+, or
  8. * Recurrence score ≥ 25
  9. * No evidence of disease
  10. * Age ≥ 18
  11. * Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy
  12. * 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)
  13. * Cleared for exercise participation as per screening clearance via PAR-Q+
  14. * Willingness to comply with all study-related procedures
  1. * Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
  2. * Any other current diagnosis of invasive cancer of any kind
  3. * Distant metastatic malignancy of any kind
  4. * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Contacts and Locations

Principal Investigator

Jessica Scott, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Natera, Inc. (Data or Specimen Analysis Only)
San Carlos, California, 94070
United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jessica Scott, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-02
Study Completion Date2025-10-02

Study Record Updates

Study Start Date2020-10-02
Study Completion Date2025-10-02

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • exercise
  • ctDNA
  • 20-378
  • Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

  • 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