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Behavioral Intervention

Exercise Prehabilitation for Esophageal Cancer

N/A

Recruiting

Led By Nathan Parker, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Biopsy-proven locoregional esophageal cancer (LEC)

Treatment plan including neoadjuvant chemoradiation therapy and surgical resection

Must not have

Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely

Myopathic or rheumatologic disease that impacts physical function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 17 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if exercise "prehabilitation" is a feasible and acceptable option for patients getting ready for surgery to remove esophageal cancer.

Who is the study for?

This trial is for individuals preparing for esophageal cancer surgery. It's designed to see if exercising before the operation, known as 'prehabilitation,' is doable and acceptable.

What is being tested?

The study tests an exercise program tailored for patients awaiting esophageal cancer resection. The focus is on whether patients can follow this regimen and how they feel about it.

What are the potential side effects?

Since the intervention involves exercise, potential side effects may include muscle soreness, fatigue, or injury related to physical activity.

Eligibility Criteria

Inclusion Criteria

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

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My esophageal cancer is confirmed by biopsy and has not spread far.

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My treatment plan includes chemotherapy, radiation before surgery.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I have a recent fracture or injury that stops me from safely doing resistance training.

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I have a muscle or joint disease affecting my physical ability.

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I do not have unstable heart or lung conditions.

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My pain level is 7 or higher on a scale of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Retention

Secondary study objectives

Clinical and treatment outcomes

Exploratory outcomes and changes

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: Exercise prehabilitationExperimental Treatment1 Intervention

In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 7Eligibility criteria met