Prehabilitation in Esophageal Cancer Care

September 24, 2021 updated by: Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre

Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Enrico M Minnella, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Prehabilitation

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

This group will receive a supervised, in-hospital training.
Behavioral: Prehabilitation
Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period
Experimental: Home-based Prehabilitation

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

This group will receive a home-based training.
Behavioral: Prehabilitation
Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption (VO2)
Time Frame: Change from baseline to 2 months after surgery
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Enrico M Minnella, MD PhD, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 15, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHC 2019-5387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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