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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
Must not have
Persons unable to provide informed consent
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 3, 6, 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand and give consent for treatment.
Select...
I do not speak English.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complication burden
Frailty assessment
Health-related quality of life (composite measure)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1280

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,429 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,935 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
Pancreatic Cancer Research Study Groups: Arm I (physical therapy consultation, exercise intervention), Arm II (best practice)
Pancreatic 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
~1 spots leftby Dec 2024
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