Esophageal Cancer Multimodal Prehabilitation Study

A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer; Esophageal Neoplasms
• Intervention / Treatment: Behavioral: Prehabilitation Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate (Feasibility)	Number of eligible patients who enroll in study	At screening
Completion Rate (Feasibility)	Defined as the number of patients who complete study procedures.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Compliance Rate (Feasibility)	Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance.	5 days
Physical Function Compliance Rate (Feasibility)	Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance.	30 days
Sleep Health Compliance Rate (Feasibility)	Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance.	30 days
Actigraphy Compliance Rate (Feasibility)	Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sarcopenia	Assessed by baseline Computed Tomography (CT) scan of the thorax.	At baseline
Malnutrition	Assessed by the Perioperative Nutrition Screen (PONS) Risk Score, a modified version of the malnutrition universal screening tool, which determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.	At baseline visit and second measure at post-operative 1 day visit
Patient-Reported Sleep Measures	Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.	At baseline visit and second measure at post-operative 1 day visit
Hand Grip Test	Assessed by change in baseline and post-operative Hand Grip tests using a hand-held dynamometer. An average score is calculated using measurements from both hands.	At baseline visit and second measure at post-operative 1 day visit
BMI	Assessed by change in baseline and post-operative height and weight.	At baseline visit and second measure at post-operative 1 day visit
Energy expenditure	Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry.	At baseline visit and second measure at post-operative 1 day visit
6-Minute Walk Test	Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance.	At baseline visit and second measure at post-operative 1 day visit
Patient-Reported Measures on Physical Function Score	Assessed by Activity Measure for Post-Acute Care (AM-PAC), a standardized assessment used to measure the physical function and functional status of patients. The AM-PAC consists of 13 tests that divided into lower and upper extremity function, gait and balance and activities of daily living and instrumental activities of daily living. Also assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), a 45-item self-reported measure to evaluate physical function.	At baseline visit and second measure at post-operative 1 day visit

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Hassan Dashti, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Esophageal Cancer; Esophageal Neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 23-085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No