← Back to Search

Exercise for Cancer

N/A

Recruiting

Led By Lee Jones, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy

Postsurgical diagnosis of high-risk colorectal cancer or high-risk breast cancer as defined by specific criteria

Must not have

Any other current diagnosis of invasive cancer of any kind

Distant metastatic malignancy of any kind

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not exercise can help lower the level of ctDNA in the blood, which may prevent cancer from returning.

Who is the study for?

This trial is for adults over 18 who've finished cancer treatment within the last 2 years for high-risk breast, prostate, or colorectal cancer. They should be non-exercisers (little to no regular exercise) and cleared for physical activity. People with other invasive cancers, serious illnesses, or those in another interventional study that could affect results are not eligible.

What is being tested?

The study is testing how aerobic exercise affects ctDNA levels in blood—a marker that might predict cancer recurrence. Researchers will determine the most beneficial and practical amount of weekly exercise to potentially prevent cancer from returning.

What are the potential side effects?

Since this trial involves exercise as an intervention, side effects may include typical risks associated with physical activity such as muscle strains, joint pain, or fatigue. The intensity of these side effects will vary based on individual fitness levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I finished my cancer treatment between 1 month and 2 years ago.

Select...

My colorectal or breast cancer is considered high-risk after surgery.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any other type of invasive cancer.

Select...

My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose-Finding/EscalationExperimental Treatment1 Intervention

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.

Group II: Dose ExpansionExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met