Researching the Effect of Exercise on Cancer

Status: closed to accrual

This phase Ia/b trial evaluates the side effects and best dose of aerobic exercise that is practical and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) in patients with previously treated high-risk solid cancers, including colorectal or breast cancer. Researchers have found that measuring ctDNA levels can help with predicting the risk of cancer, and exercise may serve as an anticancer therapy by lowering these levels. Knowledge gained from this study may provide useful information about how different levels of exercise can affect ctDNA and possibly prevent the return of disease in patients with solid cancers.

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, ** Clinical stage and post-treatment pathologic stage + estrogen receptor status and tumor grade (CPS-EG) score >= 3, ** CPS-EG score >= 2 with 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/week), 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 principal investigator (PI)
Cleared for exercise participation as per screening clearance via Physical Activity Readiness Questionnaire for Everyone (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

PRIMARY OBJECTIVES:

I. To determine recommended phase II dose (RP2D) as defined by feasibility and safety of exercise therapy administered to patients with post-treatment colorectal or breast cancer. (Phase 1a: Dose-Finding/Escalation)

II. To further evaluate the feasibility and safety of the RP2D identified in the phase 1a trial in patients with solid tumors after definitive adjuvant therapy. (Phase 1b: Dose-Expansion)

SECONDARY OBJECTIVES:

I. To assess biological activity assessed by changes in ctDNA and circulating immune phenotypes.

II. To examine the pharmacodynamics (PD) of exercise therapy as evaluated by changes in physiological (exercise capacity, body weight, blood pressure) and biological (continuous glucose monitoring, glucose response, gut microbiome) correlates.

III. To examine changes in a standard battery of patient-reported outcomes (PROs).

EXPLORATORY OBJECTIVES:

I. To explore the long-term safety, tolerability, and activity (on changes in ctDNA, PD markers, and PROs) of exercise therapy.

II. Describe relapse-free survival, as per standard of care follow-up.

III. Explore clinical and molecular predictors of response to exercise as defined by decreases in ctDNA. (Phase 1b: Dose-Expansion)

OUTLINE: This is a dose-escalation study followed by a dose expansion study.

Patients complete at-home supervised exercise sessions according to an individualized plan consisting of walking on a treadmill over 20-75 minutes daily for 3-6 days per week (a total of 90-375 minutes per week) for up to 18 months or until disease progression or withdrawal of consent, and participate in virtual visits using a tablet device. Patients also wear an activity tracker throughout the study to track physical activity, sleep patterns, and heart rate, and use a scale daily to measure their weight, fat mass, muscle mass, water weight, and bone mass. Patients also wear an optical heart rate monitor to measure changes in heart rate while exercising, and use a blood pressure monitor to measure their blood pressure every day. Patients may wear a glucose monitoring sensor and undergo a glucose tolerance test. Patients may also complete a dietary assessment by logging 3 days' worth of meals 3 times during the study using a dietary tracking application (app). Additionally, patients undergo blood sample collection throughout the study.

After completion of study intervention, patients are followed until completion of study (7 years total).

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Researching the Effect of Exercise on Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help