Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02215
Contact:
Hassan Dashti, PhD
617-726-9132
Hassan.dashti@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Hassan Dashti, PhD
6177269132
Hassan.dashti@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.