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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
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 belowSelect...
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:Select...
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.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention
Secondary outcome measures
Clinical and treatment outcomes
Exploratory outcomes and changes
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
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,520 Total Patients Enrolled
Nathan Parker, PhDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
26 Total Patients Enrolled
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