RECRUITING

A Study of Exercise Therapy in People With Solid Tumor Cancer

Conditions

Solid Tumor Cancer Exercise Therapy 24-232

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.

Official Title

Neoadjuvant Exercise Therapy in Solid Tumors: A Phase 1b Dose Expansion Trial

Quick Facts

Study Start:2024-09-12

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06597786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer. * Age ≥18 years. * An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance. * Measurable disease based on standard of care radiology scans or confirmation by the surgeon. * Body weight ≤ 385 lbs (≤ 174 kg) * Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey. * Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist. * Willingness to comply with all study-related procedures	* Distant metastases. * Receiving any form of antitumor therapy. * Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes. * Any other diagnosis of invasive cancer currently requiring active treatment. * Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

Inclusion Criteria

Exclusion Criteria

* Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer.
* Age ≥18 years.
* An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance.
* Measurable disease based on standard of care radiology scans or confirmation by the surgeon.
* Body weight ≤ 385 lbs (≤ 174 kg)
* Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey.
* Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist.
* Willingness to comply with all study-related procedures

* Distant metastases.
* Receiving any form of antitumor therapy.
* Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes.
* Any other diagnosis of invasive cancer currently requiring active treatment.
* Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

Contacts and Locations

Study Contact

Lee Jones, PhD

CONTACT

646-888-8103

jonesl3@mskcc.org

Neil Iyengar, MD

CONTACT

646-888-4714

Principal Investigator

Lee Jones, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Lee Jones, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-12

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-09-12

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Exercise Therapy
24-232

Additional Relevant MeSH Terms

Solid Tumor Cancer