Prehabilitation in Esophageal Cancer Care

Not Applicable

• Conditions: Esophageal Cancer

• Registration Number: NCT04581005
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2019-08-19
• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-06
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygen consumption (VO2)	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)

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada