A Study of Exercise Therapy in People With Solid Tumor Cancer

NCT06597786 | Withdrawn Phase 1

• 1 other identifier: 24-232
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumor Cancer

Keywords

Exercise Therapy; 24-232

Outcome Measures

Primary Outcomes (1)

• change in Ki67 values

  With at least one pretreatment (baseline) or postintervention measurement of Ki67 will be considered evaluable. 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. The biopsies will be collected as part of the standard medical care.

  up to 3 years

Study Arms (1)

Exercise therapy

EXPERIMENTAL

Exercise therapy will comprise individualized treadmill walking delivered up to 5 times weekly (over a 7-day period) to achieve a weekly cumulative dose of 225 minutes per week. The minimum treatment period will be 3 weeks. Exercise therapy will be administered via a patient-centric, decentralized platform: Digital Platform for Exercise (DPEx). DPEx will permit all study procedures to be conducted remotely in patients' homes.

Other: Exercise therapy

Interventions

Exercise therapy OTHER

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.

Exercise therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Lee Jones, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, open-label, phase 1b dose-expansion trial of neoadjuvant (preoperative) exercise therapy in patients with prespecified solid tumors.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share