← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,217 Total Patients Enrolled
202 Trials studying Breast Cancer
95,099 Patients Enrolled for Breast Cancer
Lee Jones, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
5,051 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04589468 — N/A
Breast Cancer Research Study Groups: Dose-Finding/Escalation, Dose Expansion
Breast Cancer Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04589468 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04589468 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are implementing this research project?

"This protocol has sites located in 8 distinct locations such as Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale, Memorial Sloan Kettering Cancer Center New york City, and Memoral Sloan Kettering Westchester (Limited Protocol Activities) Harrison."

Answered by AI

What is the upper limit for participant enrollment in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this investigation has been publicly posted since October 2nd 2020 and is actively seeking participants for its research objectives. A total of 70 subjects are required from 8 trial sites."

Answered by AI

Are any new participants being admitted to this research project?

"Affirmative. The clinical trial listing on the clinicaltrials.gov website confirms this study's active recruitment status, which began in October 2nd 2020 and was last revised August 24th 2022. This medical experiment seeks to enroll 70 patients from 8 different hospitals or clinics."

Answered by AI
~9 spots leftby Oct 2024