A Study of Exercise Therapy in People With Solid Tumor Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-12

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise therapy

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.

Group Type EXPERIMENTAL

Exercise therapy

Intervention Type 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.

Interventions

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Exercise therapy

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No