Exercise Prehabilitation for Locoregional Esophageal Cancer

December 3, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute

Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study

The purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Jose Pimiento, MD
        • Principal Investigator:
          • Nathan Parker, PhD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy-proven locoregional esophageal cancer (LEC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
  • Ability to read and speak English

Exclusion Criteria:

  • Regular engagement in resistance training (2x/week targeting all major muscle groups)
  • Screen failure for exercise safety based on PAR-Q
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely
  • Numeric pain rating scale of 7 or more out of 10
  • Myopathic or rheumatologic disease that impacts physical function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise prehabilitation
In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.
Behavioral: Exercise
Physical activity and resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Up to 11 weeks
The number of participants who complete T0 and T1 measures.
Up to 11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcomes and changes
Time Frame: Up to 17 weeks
The number of participants who demonstrate improvements in exploratory outcome measures.
Up to 17 weeks
Clinical and treatment outcomes
Time Frame: Up to 17 weeks
Chi-square testing will be used to determine if there's a difference in perioperative outcomes between groups.
Up to 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Nathan Parker, PhD, Moffitt 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 Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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