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Clinical Trials/NCT04581005
NCT04581005
Unknown
Not Applicable

Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country54 target enrollmentAugust 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
54
Locations
1
Primary Endpoint
Oxygen consumption (VO2)
Last Updated
4 years ago

Overview

Brief Summary

Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

Detailed Description

While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT). Multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.

Registry
clinicaltrials.gov
Start Date
August 19, 2019
End Date
November 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Franco Carli

Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.

Exclusion Criteria

  • co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition

Outcomes

Primary Outcomes

Oxygen consumption (VO2)

Time Frame: Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)

Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)

Study Sites (1)

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