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Behavioral Intervention

Prehabilitation Program for Esophageal Cancer

N/A

Recruiting

Led By Hassan Dashti, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer

At least four weeks to esophageal cancer surgery

Must not have

Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.

Women who are pregnant, nursing, or at risk of becoming pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if pre-surgery health program can help older people with esophageal cancer prepare for surgery.

Who is the study for?

This trial is for English-speaking adults aged 65 and over with esophageal cancer, who have completed neoadjuvant therapy and are awaiting surgery. They must be able to participate in physical activities and not have skin issues that interfere with sensor use. Pregnant women or those in other studies are excluded.

What is being tested?

The study tests a prehabilitation program designed to boost patients' fitness, nutrition, and sleep before their esophageal cancer surgery. It aims to see if this approach is practical for older patients at higher risk due to their condition.

What are the potential side effects?

Since the intervention involves non-medical procedures like exercise, nutritional guidance, and sleep improvement strategies, side effects may include muscle soreness from physical activity or potential dietary changes but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have finished treatment before surgery for esophageal cancer.

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My esophageal cancer surgery is scheduled in at least 4 weeks.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe physical disability that prevents me from doing any form of exercise.

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I am not pregnant, nursing, or at risk of becoming pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion Rate (Feasibility)

Enrollment Rate (Feasibility)

Secondary study objectives

Actigraphy Compliance Rate (Feasibility)

Nutrition Compliance Rate (Feasibility)

Physical Function Compliance Rate (Feasibility)

+1 more

Other study objectives

6-Minute Walk Test

BMI

Energy expenditure

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prehabilitation ProgramExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation Program

2018

Completed Early Phase 1

~100

0 / 5Eligibility criteria met