Esophageal Cancer Multimodal Prehabilitation Study

NCT ID: NCT06027515

Last Updated: 2025-11-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-01-31

Brief Summary

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The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.

Detailed Description

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This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer.

Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans.

Participation in this research study is expected to last 7 months.

It is expected about 30 patients will participate in this study.

Conditions

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Esophageal Cancer Esophageal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prehabilitation Program

30 participants will be enrolled and will complete study procedures as follows:

* Enrollment at least 4 weeks prior to esophageal cancer surgery.
* In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator.
* Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement.
* Regular electronic/phone-call check-ins with study staff.
* Telehealth appointment with physical therapist and dietitian prior to surgery.
* After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires.
* 6-month follow-up period.

Group Type EXPERIMENTAL

Prehabilitation Program

Intervention Type BEHAVIORAL

Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.

Interventions

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Prehabilitation Program

Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 65 years of age and over
* Adult male or non-pregnant female volunteers
* Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer
* At least four weeks to esophageal cancer surgery
* Without skin conditions that preclude wearing sensors
* Able to speak English and consent

Exclusion Criteria

* Participants in any other interventional study that may bias results or limit study adherence during our study
* Dietary restrictions that prevent consumption of nutritional supplements
* Women who are pregnant, nursing, or at risk of becoming pregnant
* Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hassan Dashti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hassan Dashti, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hassan Dashti, PhD

Role: CONTACT

6177269132

Federico Ciardi, MBBS

Role: CONTACT

646-574-7682

Facility Contacts

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Hassan Dashti, PhD

Role: primary

6177269132

Other Identifiers

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23-085

Identifier Type: -

Identifier Source: org_study_id

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