NCT04602026

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adult Liver Carcinoma
• Gastric Carcinoma
• Malignant Solid Neoplasm
• Pancreatic Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-14
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2020-10-26
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States