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Exercise and Nutritional Counseling for Pancreatic Cancer

N/A
Recruiting
Led By Elizabeth Hile, PhD, PT
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to rise from a chair and walk household distances without assist from another person.
Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trial is testing if a pre-surgery exercise and diet program can improve outcomes for pancreatic cancer patients.

Who is the study for?
This trial is for individuals over 30 with suspected pancreatic or related tumors who are fit to exercise and can understand English. They must be able to move without help, agree to random assignment in home-based exercise programs, and use protein supplements if needed. Those already on a substantial exercise or protein regimen may only join the observational part of the study.Check my eligibility
What is being tested?
Participants will receive dietary counseling and engage in home exercises at high frequency before surgery for pancreatic cancer. The study tests two types of pre-surgery 'prehabilitation': standard vs enhanced (with resistance training) exercises, aiming to improve physical function and quality of life within 2-3 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks include those generally associated with new exercise regimens such as muscle soreness, fatigue, or injury. Allergic reactions could occur from whey protein supplementation if not previously identified.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk around my house without help.
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I am willing to follow a random home exercise program and take protein if told to.
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I am approved for surgery on a pancreatic-related tumor and cleared for exercise by the clinic team.
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I am older than 30 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accrual
Adherence
Retention
Secondary outcome measures
Assessment of Symptoms
Change in Body Weight
Physical Performance
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard Exercise GroupExperimental Treatment2 Interventions
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
Group II: Enhanced Exercise GroupExperimental Treatment2 Interventions
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Exercise
2013
N/A
~180
Nutritional Counseling
2016
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,460 Total Patients Enrolled
Elizabeth Hile, PhD, PTPrincipal InvestigatorFaculty

Media Library

Enhanced Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03256201 — N/A
Pancreatic Cancer Research Study Groups: Enhanced Exercise Group, Standard Exercise Group
Pancreatic Cancer Clinical Trial 2023: Enhanced Exercise Highlights & Side Effects. Trial Name: NCT03256201 — N/A
Enhanced Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03256201 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for patients to enroll in this trial?

"This clinical trial is open for recruitment, as noted on the clinicaltrials.gov website. It was initially posted 4 years ago and recently modified in February 2022."

Answered by AI

How many individuals have been inducted into this trial thus far?

"Absolutely, the information readily accessible on clinicaltrials.gov attests to this trial's active recruitment of participants. It was initially posted on February 1st 2016 and last updated April 2nd 2022; 150 patients are needed from a single site for enrolment in the study."

Answered by AI

What goals are researchers aiming to accomplish through this clinical trial?

"The primary focus of this two year long trial is to measure Adherence, while secondary objectives involve evaluating the efficacy of Functional Assessment of Anorexia-Cachexia Therapy - FAACT (V1-V2), MD Anderson Brief Fatigue Inventory (BFI) Severity and Interference Scores at first post operative visit, as well as assessing changes in baseline body weight in pounds at second postoperative visit."

Answered by AI
~16 spots leftby Apr 2025