Clinical Trials /

Researching the Effect of Exercise on Cancer

NCT04589468

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.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Researching the Effect of Exercise on Cancer
  • Official Title: Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer

Clinical Trial IDs

  • ORG STUDY ID: 20-378
  • NCT ID: NCT04589468

Conditions

  • 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

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalFifty (n=50) patients with post-treatment breast, prostate, or colorectal cancer and detectable ctDNA. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
    Dose ExpansionExperimentalAn independent cohort of 36 post-treatment patients with breast, prostate, or colorectal cancer (n=12 per type) and detectable ctDNA. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Postsurgical diagnosis of stage 1-3 breast, prostate, or colorectal cancer
      
                -  No evidence of disease as per standard imaging
      
                -  Age ≥ 18
      
                -  Detectable ctDNA
      
                -  Interval of ≥ 6 months but ≤ 10 years following completion of all therapy (patients
                   currently on hormonal therapy for at least one year are eligible)
      
                -  Access and sufficient quantity of banked formalin-fixed or frozen primary tumor tissue
                   (to profile tumor somatic mutation landscape)
      
                -  Non-exercising (i.e., ≤ 60 mins of moderate or vigorous exercise/wk, as assessed by
                   remote activity and heart rate tracking for a 7-day period prior to plasma analysis of
                   ctDNA)
      
                -  Cleared for exercise participation as per screening clearance via PAR-Q+
      
              Exclusion Criteria:
      
                -  Use of any selective estrogen receptor modulator or aromatase inhibitor within 3
                   months of study entry
      
                -  Enrollment onto any other interventional investigational study
      
                -  Men receiving GNRH agonists and antagonists as well as any antiandrogens
      
                -  Any other current diagnosis of invasive cancer of any kind
      
                -  Distant metastatic malignancy of any kind
      
                -  Type 2 diabetes
      
                -  Any other condition or intercurrent illness that, in the opinion of the investigator,
                   makes the subject a poor candidate for study participation
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
      Time Frame:24 weeks
      Safety Issue:
      Description:Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., <60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Memorial Sloan Kettering Cancer Center

      Trial Keywords

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

      Last Updated

      October 9, 2020