Esophageal Cancer Multimodal Prehabilitation Study

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; Esophageal Neoplasms

• Registration Number: NCT06027515
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2023-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-10-18
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sleep Health Compliance Rate (Feasibility)	30 days	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.
Nutrition Compliance Rate (Feasibility)	5 days	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.
Physical Function Compliance Rate (Feasibility)	30 days	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.
Actigraphy Compliance Rate (Feasibility)	30 days	Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States