Prehabilitation in Esophageal Cancer Care

Esophageal Cancer Clinical Trial

Official title:

Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581005
• Other study ID #: MUHC 2019-5387
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: November 2022

Study information

• Verified date: September 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Francesco Carli, MD MPhil
• Phone: 514-934-1934
• Email: franco.carli[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Behavioral:
• Prehabilitation
Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption (VO2)	Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)	Change from baseline to 2 months after surgery
Primary	Oxygen consumption (VO2)	Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)	Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)