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Prehabilitation Program for Cancer Surgery (RIOT Trial)

N/A

Waitlist Available

Led By Mark Rubinstein, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for any abdominal (e.g., pancreatic, liver or gastric) cancer surgery or established in the GI surgical oncology clinics

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 3, 6, 12 months

Awards & highlights

RIOT Trial Summary

This trial is studying 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.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions include best practices, exercise programs, physical therapy, and questionnaires rather than medications, traditional side effects are not expected. However, participants may experience fatigue or discomfort from increased physical activity.

RIOT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery related to abdominal cancer.

RIOT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 3, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complication burden

Frailty assessment

Health-related quality of life (composite measure)

+1 more

RIOT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (physical therapy consultation, exercise intervention)Experimental Treatment3 Interventions

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

Group II: Arm II (best practice)Active Control2 Interventions

Patients receive standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

Physical Therapy

2020

Completed Phase 4

~1460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,101 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,601 Total Patients Enrolled

Mark Rubinstein, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04602026 — N/A

Stomach Cancer Research Study Groups: Arm I (physical therapy consultation, exercise intervention), Arm II (best practice)

Stomach Cancer Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT04602026 — N/A

Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04602026 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible for individuals to join this clinical trial?

"Clinicaltrials.gov verifies that this investigation is actively searching for volunteers, having been first announced on the 14th of September 2020 and subsequently revised on November 23rd 2022."

Answered by AI

What is the enrollment quota for this clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this medical research is currently looking for participants. It was first posted in September of 2020 and edited most recently in November of 2022; 144 patients are needed from a single trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mark Rubinstein 2020. "The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04602026.

All > No Stomach For Cancer > Gastric Cancer