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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedFebruary 12, 2026
February 1, 2026
2.2 years
August 22, 2023
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Nutrition Compliance Rate (Feasibility)
5 days
Physical Function Compliance Rate (Feasibility)
30 days
Sleep Health Compliance Rate (Feasibility)
30 days
Actigraphy Compliance Rate (Feasibility)
30 days
Other Outcomes (8)
Sarcopenia
At baseline
Malnutrition
At baseline visit and second measure at post-operative 1 day visit
Patient-Reported Sleep Measures
At baseline visit and second measure at post-operative 1 day visit
- +5 more other outcomes
Study Arms (1)
Prehabilitation Program
EXPERIMENTAL30 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hassan Dashti, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 22, 2023
First Posted
September 7, 2023
Study Start
December 1, 2023
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.