The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
NCT04602026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-04-04
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.
Conditions
- Adult Liver Carcinoma
- Gastric Carcinoma
- Malignant Solid Neoplasm
- Pancreatic Carcinoma
Interventions
- OTHER
-
Best Practice
Receive standard of care
- BEHAVIORAL
-
Exercise Intervention
Complete home exercise intervention
- PROCEDURE
-
Physical Therapy
Undergo physical therapy
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Mark Rubinstein, PhD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-14
- Primary Completion
- 2024-12-09
- Completion
- 2024-12-09
Countries
- United States
Study Locations
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