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Exercise Therapy before Surgery in Patients with Resectable Solid Tumors, PRESTO-2 Trial
Trial Status: temporarily closed to accrual
This clinical trial tests the effectiveness of exercise therapy done before standard surgery in patients with solid tumor cancers that can be removed by surgery (resectable). The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). Researchers think exercise can help regulate the way the cells in the body interact with each other. By regulating signals sent between cells, exercise may help improve outcomes of cancer treatments.
Inclusion Criteria
Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naive 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 principal investigator (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06597786.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
Middletown
Memorial Sloan Kettering Monmouth
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
Montvale
Memorial Sloan Kettering Bergen
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
New York
Commack
Memorial Sloan Kettering Commack
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
New York
Memorial Sloan Kettering Cancer Center
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
Uniondale
Memorial Sloan Kettering Nassau
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
West Harrison
Memorial Sloan Kettering Westchester
Status: Temporarily closed to accrual
Contact: Lee Winston Jones
Phone: 646-888-8103
PRIMARY OBJECTIVE:
I. To characterize biological activity of neoadjuvant exercise therapy as defined by the change in tumor cell proliferation marker (Ki67) evaluated in paired formalin-fixed paraffin embedded (FFPE) tumor samples obtained before (diagnostic biopsy) and after (surgical resection) exercise therapy.
SECONDARY OBJECTIVES:
I. To characterize biological activity of neoadjuvant exercise therapy as defined by the proportion of patients who have a 10% reduction in Ki67 from before exercise therapy to after exercise therapy.
II. To characterize tumor clinical activity (pathological response) evaluated in paired FFPE tumor samples obtained before and after exercise therapy.
III. To characterize the feasibility and safety of neoadjuvant exercise therapy by assessing compliance, surgical delays, change in surgical-intent, surgical complications, and safety (type and prevalence of adverse events).
IV. To characterize changes in lifestyle patterns and patient physiology during the exercise therapy intervention including changes in mobility, sleep, exercise capacity, and body composition.
EXPLORATORY OBJECTIVES:
I. To explore the antitumor activity of exercise therapy by evaluating radiographic response and down-staging at the time of surgery.
II. To explore the association between frequently mutated genes and tumor response to neoadjuvant exercise therapy.
III. To collect and bank blood for future correlative studies.
OUTLINE:
Patients perform individualized, home-based supervised treadmill walking sessions over 45 minutes each, 5 times a week for a total of 225 minutes per week, following a non-linear schedule for 3-6 weeks. If a patient is unable to complete supervised sessions, patients may be assigned temporary unsupervised training sessions. Patients 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 and may receive a treadmill to perform exercise therapy sessions on study. Additionally, patients undergo blood sample collection on study. Patients' previously collected tissue samples are collected during baseline and at the time of surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
