Esophageal Cancer Multimodal Prehabilitation Study
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
- Esophageal Cancer
- Esophageal Neoplasms
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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.