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Prehabilitation in Esophageal Cancer Care

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Prehabilitation

About this trial

This is an interventional supportive care trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McGill University Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Supervised Prehabilitation

Home-based Prehabilitation

Arm Description

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training.

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training.

Outcomes

Primary Outcome Measures

Oxygen consumption (VO2)

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

Oxygen consumption (VO2)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04581005

First Posted

August 15, 2020

Last Updated

September 24, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04581005

Brief Title

Prehabilitation in Esophageal Cancer Care

Official Title

Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 19, 2019 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supervised Prehabilitation

Arm Type

Experimental

Arm Description

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training.

Arm Title

Home-based Prehabilitation

Arm Type

Experimental

Arm Description

Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training.

Intervention Type

Behavioral

Intervention Name(s)

Prehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Oxygen consumption (VO2)

Description

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

Time Frame

Change from baseline to 2 months after surgery

Title

Oxygen consumption (VO2)

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Carli, MD MPhil

Phone

514-934-1934

Ext

43274

franco.carli@mcgill.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Enrico M Minnella, MD PhD

Phone

514-934-1934

Ext

43274

enrico.minnella@mail.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enrico M Minnella, MD PhD

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesco Carli, MD MPhil

Phone

5149341934

Ext

43728

franco.carli@mcgill.ca

First Name & Middle Initial & Last Name & Degree

Enrico M Minnella, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

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Prehabilitation in Esophageal Cancer Care

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