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NCT06027515 | RECRUITING | Esophageal Cancer


Esophageal Cancer Multimodal Prehabilitation Study
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Hassan Dashti

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.

Condition or disease

Esophageal Cancer

Esophageal Neoplasms

Intervention/treatment

Prehabilitation Program

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery
Actual Study Start Date : 2023-12-01
Estimated Primary Completion Date : 2025-10-18
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

Esophageal Cancer Multimodal Prehabilitation Study

Location Details

NCT06027515


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How to Participate

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Locations


RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02215

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