Trial Title:
A Study of Exercise Therapy in People With Solid Tumor Cancer
NCT ID:
NCT06597786
Condition:
Solid Tumor Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Exercise Therapy
24-232
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A single-center, open-label, phase 1b dose-expansion trial of neoadjuvant (preoperative)
exercise therapy in patients with prespecified solid tumors.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise therapy
Description:
Patients will receive a study kit which includes a smart watch (for monitoring of
mobility / lifestyle patterns), heart rate monitor, blood pressure cuff, scale, and
e-tablet. Patients may receive a treadmill to perform exercise therapy sessions. The
treadmills and study kits are MSK owned equipment that will be deployed to the patients'
homes and returned at the end of the study.
Arm group label:
Exercise therapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited protocol activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Jones, PhD
Phone:
646-888-8103
Contact backup:
Last name:
Neil Iyengar, MD
Phone:
646-888-4714
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Jones, MD
Phone:
212-639-6428
Start date:
September 12, 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06597786
http://www.mskcc.org/mskcc/html/44.cfm
