Exercise Prehabilitation for Locoregional Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Behavioral: Exercise

• Registration Number: NCT06430346
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise prehabilitation	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Retention	Up to 11 weeks	The number of participants who complete T0 and T1 measures.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States