Recruiting

Prehabilitation

Sponsor:

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

Code:

NCT04581005

Conditions

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation

Study Details

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.

Conditions

Esophageal Cancer

Study ID

NCT04581005

Start date

Aug 19, 2019

Status verified date

Sep, 2021

Completion date

Nov, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supervised Prehabilitation

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.

This group will receive a supervised, in-hospital training.

experimental: Home-based Prehabilitation

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.

This group will receive a home-based training.

Interventions

Prehabilitation

Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period

Primary outcome measure

  • Oxygen consumption (VO2) [ Time Frame: Change from baseline to 2 months after surgery ]
  • Oxygen consumption (VO2) [ Time Frame: Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks) ]

Central Contacts and Locations

Central contacts

Francesco Carli, MD MPhil

514-934-1934franco.carli@mcgill.ca

Enrico M Minnella, MD PhD

514-934-1934enrico.minnella@mail.mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Francesco Carli, MD MPhil

5149341934franco.carli@mcgill.ca

Principal Investigator:

Enrico M Minnella, MD PhD

More Information

Sponsor

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

Last update posted

Sep 28, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2021-09-28.