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Prehabilitation in Esophageal Cancer Care

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McGill University

Status

Unknown

Conditions

Esophageal Cancer

Treatments

Behavioral: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04581005
MUHC 2019-5387

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

Supervised Prehabilitation
Experimental group
Description:
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training.
Treatment:
Behavioral: Prehabilitation
Home-based Prehabilitation
Experimental group
Description:
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training.
Treatment:
Behavioral: Prehabilitation

Trial contacts and locations

1

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Central trial contact

Francesco Carli, MD MPhil; Enrico M Minnella, MD PhD

Data sourced from clinicaltrials.gov

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