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Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

NCT03256201 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-08-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Nutritional Counseling

Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.

BEHAVIORAL

Standard Exercise

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.

BEHAVIORAL

Enhanced Exercise

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Elizabeth Hile, PhD, PT · Faculty

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2024-04-01
Completion
2025-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03256201 on ClinicalTrials.gov