Esophageal Cancer Multimodal Prehabilitation Study

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027515
• Other study ID #: 23-085
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Hassan Dashti, PhD
• Phone: 6177269132
• Email: Hassan.dashti[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2026
• Est. primary completion date: October 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sarcopenia	Assessed by baseline Computed Tomography (CT) scan of the thorax.	At baseline
Other	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
Other	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
Other	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
Other	BMI	Assessed by change in baseline and post-operative height and weight.	At baseline visit and second measure at post-operative 1 day visit
Other	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
Other	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
Other	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
Primary	Enrollment Rate (Feasibility)	Number of eligible patients who enroll in study	At screening
Primary	Completion Rate (Feasibility)	Defined as the number of patients who complete study procedures.	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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