Exercise and Nutritional Counseling for Pancreatic Cancer

Overseen By Rachel Neuhold, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Unsafe to exercise, Whey allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

Research Team

Elizabeth Hile, PhD, PT

Principal Investigator

Faculty

Eligibility Criteria

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.

Inclusion 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.

I can walk around my house without help.

Exclusion Criteria

You cannot be allergic to whey protein, and you should not have any trouble with walking and strength tests.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Prehabilitation

Participants undergo a home-based exercise program with dietary counseling for 2-3 weeks prior to surgery

2-3 weeks

Daily exercise sessions, follow-up phone calls

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

First post-operative visit

Long-term Follow-up

Participants' retention, adherence, and quality of life are assessed over a 2-year period

2 years

Treatment Details

Interventions

• Enhanced Exercise
• Nutritional Counseling
• Standard Exercise

Trial Overview 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.

Participant Groups

Group I: Standard Exercise Group Experimental Treatment 2 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 Group Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+