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NCT06430346 Clinical Trial

Exercise Prehabilitation for Locoregional Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:
Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06430346
Other study ID # MCC-23121
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 21, 2024
Est. completion date May 2027

Study information
Verified date June 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Nathan Parker, PhD
Phone 813-745-6849
Email Nathan.Parker@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise
Physical activity and resistance training

Locations
Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retention The number of participants who complete T0 and T1 measures. Up to 11 weeks
Secondary Exploratory outcomes and changes The number of participants who demonstrate improvements in exploratory outcome measures. Up to 17 weeks
Secondary Clinical and treatment outcomes Chi-square testing will be used to determine if there's a difference in perioperative outcomes between groups. Up to 17 weeks
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