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The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer — RIOT  

Malignant Solid Neoplasm Clinical Trial

Official title:
Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)

Clinical Trial Summary

This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients. II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients. OUTLINE: All patients enrolled (both frail and non-frail) will be randomized (1:1) at the time of enrollment to receive pre-operative exercise or non-preoperative exercises. Randomization will be stratified by frailty status. ARM I: Enrolled patients undergo a physical therapy consultation and complete home exercises 3 days per week, in addition to standard guidelines. ARM II: Enrolled patients follow standard guidelines. All patients are followed up at 2 weeks after surgery and then every 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04602026
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date September 14, 2020
Completion date December 31, 2024
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