Status:
ACTIVE_NOT_RECRUITING
Exercise and Nutrition to Improve Pancreatic Cancer Outcomes
Lead Sponsor:
University of Oklahoma
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
30+ years
Phase:
NA
Brief 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,...
Detailed Description
This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resect...
Eligibility Criteria
Inclusion
- Inclusion:
- Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team.
- Cognition and English language skills must be sufficient for completion of consent and questionnaires.
- Age \>30.
- 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.
- Exclusion:
- Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns.
- Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength.
- Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.
Exclusion
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03256201
Start Date
February 1 2016
End Date
March 1 2025
Last Update
August 16 2024
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104