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Exercise and Nutritional Counseling for Pancreatic Cancer
N/A
Waitlist Available
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.
Age >30.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I can walk around my house without help.
Select...
I am older than 30 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accrual
Adherence
Retention
Secondary study objectives
Assessment of Symptoms
Change in Body Weight
Physical Performance
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
473 Previous Clinical Trials
93,586 Total Patients Enrolled
Elizabeth Hile, PhD, PTPrincipal InvestigatorFaculty
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow a random home exercise program and take protein if told to.I am approved for surgery on a pancreatic-related tumor and cleared for exercise by the clinic team.You cannot be allergic to whey protein, and you should not have any trouble with walking and strength tests.I can walk around my house without help.I am in a regular strength or protein program, so I can only join the study's observational part.I am not excluded from the study due to safety concerns related to exercise.I am older than 30 years.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Exercise Group
- Group 2: Standard Exercise Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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