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

Not Applicable

Completed

• Conditions: Adult Liver Carcinoma; Malignant Solid Neoplasm; Pancreatic Carcinoma; Gastric Carcinoma
• Interventions: Other: Best Practice; Behavioral: Exercise Intervention; Procedure: Physical Therapy; Other: Questionnaire Administration

• Registration Number: NCT04602026
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2020-09-14
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Scheduled for any abdominal (e.g., pancreatic, liver or gastric) cancer surgery or established in the GI surgical oncology clinics or
• Scheduled for neoadjuvant therapy prior with the plan to be scheduled for surgery

Exclusion Criteria

• Non-English speaking
• Prisoners
• Persons unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (best practice)	Best Practice	Patients receive standard of care.
Arm I (physical therapy consultation, exercise intervention)	Physical Therapy	Patients undergo a physical therapy consultation and complete home exercises 3 days per week.
Arm I (physical therapy consultation, exercise intervention)	Questionnaire Administration	Patients undergo a physical therapy consultation and complete home exercises 3 days per week.
Arm I (physical therapy consultation, exercise intervention)	Exercise Intervention	Patients undergo a physical therapy consultation and complete home exercises 3 days per week.
Arm II (best practice)	Questionnaire Administration	Patients receive standard of care.

Primary Outcome Measures

Name	Time	Method
Morbidity	Baseline	Will be assessed using standardized case report forms.
Frailty assessment	Baseline	A rapid assessment for frailty using the widely used 5-item fatigue, resistance, ambulation, illness, \& loss of weight (FRAIL) questionnaire will be performed. Patients are identified as frail by scoring 2 or more points on the FRAIL questionnaire. The frailty assessment will be aimed at identifying factors related to the 6 characteristics of frailty: physical performance, gait speed, mobility, nutritional status, mental health and cognition.
Health-related quality of life (composite measure)	Baseline, 2 weeks, 3, 6, 12 months	Will be recorded by administration of the Patient Reported Outcomes Measurement Information System (PROMIS) health-related quality of life questionnaire. PROMIS is a validated set of patient-centered measures that evaluates and monitors life domains (physical, mental, social health) and provide standardized patient reported outcome resources for use in clinical research and practice.
Complication burden	Baseline	Will be calculated using the Comprehensive Complication Index (CCI). This method is more powerful than standard binary measures of morbidity (presence/absence of individual events) as it presents a quantitative score based on an aggregate weighted total ranging from 0 (no complications) to 100 (death).

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States