Prehabilitation in Esophageal Cancer Care

NCT ID: NCT04581005

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Supervised Prehabilitation

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

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

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

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

Home-based Prehabilitation

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

This group will receive a home-based training.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Prehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Franco Carli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrico M Minnella, MD PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Francesco Carli, MD MPhil

Role: CONTACT

514-934-1934 ext. 43274

Enrico M Minnella, MD PhD

Role: CONTACT

514-934-1934 ext. 43274

Facility Contacts

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Francesco Carli, MD MPhil

Role: primary

5149341934 ext. 43728

Other Identifiers

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MUHC 2019-5387

Identifier Type: -

Identifier Source: org_study_id

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