Researching the Effect of Exercise on Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Stage II Colorectal Cancer; Breast Cancer; Stage III Colorectal Cancer; Stage I Colorectal Cancer; Stage I Breast Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage II Prostate Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04589468

20-378

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Dose-Finding/Escalation

Experimental group

Description:

Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. 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.

Treatment:

Other: Exercise

Dose Expansion

Experimental group

Description:

An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. 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.

Treatment:

Other: Exercise