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

The Ohio State University

Status: Completed

Conditions: Gastric Carcinoma; Malignant Solid Neoplasm; Adult Liver Carcinoma; Pancreatic Carcinoma

Treatments: Behavioral: Exercise Intervention; Other: Best Practice; Procedure: Physical Therapy; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04602026

NCI-2020-04925 (Registry Identifier)

OSU-20057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Arm I (physical therapy consultation, exercise intervention)

Experimental group

Description:

Patients undergo a physical therapy consultation and complete home exercises 3 days per week.

Treatment:

Other: Questionnaire Administration

Procedure: Physical Therapy

Behavioral: Exercise Intervention

Arm II (best practice)

Active Comparator group

Description:

Patients receive standard of care.

Treatment:

Other: Questionnaire Administration

Other: Best Practice