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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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