Prehabilitation Program for Cancer Surgery

(RIOT Trial)

Overseen By Aslam Ejaz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-English speaking, prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mark Rubinstein, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for frail patients who are scheduled for abdominal cancer surgery (pancreatic, liver, or gastric) or planned to have it after neoadjuvant therapy. It's aimed at those who can provide informed consent and speak English. People in prison or unable to give consent cannot participate.

Inclusion Criteria

I am planned for treatment to shrink my tumor before surgery.

I am scheduled for surgery related to abdominal cancer.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a prehabilitation program including physical therapy consultation and home exercises 3 days per week

Pre-surgery period

Surgery

Participants undergo surgery for pancreatic, liver, or gastric cancer

Follow-up

Participants are monitored for safety and effectiveness after surgery

12 months

Follow-up at 2 weeks post-surgery and every 3 months

Treatment Details

Interventions

• Best Practice
• Exercise Intervention
• Physical Therapy
• Questionnaire Administration

Trial Overview The study is testing a prehabilitation program designed to improve patient health before surgery against the usual care given before such surgeries. The goal is to see if this program leads to better recovery outcomes for patients with pancreatic, liver, or gastric cancer.

Participant Groups

Group I: Arm I (physical therapy consultation, exercise intervention) Experimental Treatment 3 Interventions

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

Group II: Arm II (best practice) Active Control 2 Interventions

Patients receive standard of care.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+