Adult Liver CarcinomaRIOTNCT04602026
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
A study testing Best Practice, Exercise Intervention and Physical Therapy in people with Adult Liver Carcinoma and Gastric Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Liver Carcinoma, Gastric Carcinoma, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Exercise Intervention and Physical Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Prisoners
- Persons unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Best Practice, Exercise Intervention, Physical Therapy, Questionnaire Administration
- Medical subject headings
- Carcinoma, Hepatocellular, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Exercise InterventionBehavioural
Complete home exercise intervention
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Undergo physical therapy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (physical therapy consultation, exercise intervention) | Experimental | Patients undergo a physical therapy consultation and complete home exercises 3 days per week. Receives: Behavioral: Exercise Intervention; Procedure: Physical Therapy; Other: Questionnaire Administration |
| Arm II (best practice) | Active comparator | Patients receive standard of care. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty assessment
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.
Measured: Baseline
Morbidity
Will be assessed using standardized case report forms.
Measured: Baseline
Complication burden
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).
Measured: Baseline
Health-related quality of life (composite measure)
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.
Measured: Baseline, 2 weeks, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start14 Sep 2020
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Rubinstein, Ohio State University Comprehensive Cancer Center
- Investigators
- Mark Rubinstein, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602026
- Sponsor's protocol ID
- OSU-20057
- Other IDs
- NCI-2020-04925
- Acronym
- RIOT
- Status last verified
- Apr 2025
- First submitted
- 20 Oct 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamad A, Zhang H, Zhang Y, Shen C, Fa P, Huang H, Ejaz A, Tsung A. Understanding the mechanism behind preoperative exercise therapy in patients with gastrointestinal cancers: a prospective randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Mar 14;17(1):50. doi: 10.1186/s13102-025-01094-6.
PubMed 40087747
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)
- ClinicalTrials.gov ID
- NCT04602026
- Acronym / sponsor ID
- RIOT / OSU-20057
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (physical therapy consultation, exercise intervention) | Experimental | Behavioral: Exercise Intervention, Procedure: Physical Therapy, Other: Questionnaire AdministrationPatients undergo a physical therapy consultation and complete home exercises 3 days per week. |
| Arm II (best practice) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Non-English speaking
- Prisoners
- Persons unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm II (best practice) |
| Exercise InterventionComplete home exercise intervention | Behavioural | Arm I (physical therapy consultation, exercise intervention) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureUndergo physical therapy | Procedure or surgery | Arm I (physical therapy consultation, exercise intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (physical therapy consultation, exercise intervention), Arm II (best practice) |
Primary outcome
Frailty assessment
Time frame: 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.
Morbidity
Time frame: Baseline
Will be assessed using standardized case report forms.
Complication burden
Time frame: 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).
Health-related quality of life (composite measure)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 40087747Hamad A, Zhang H, Zhang Y, Shen C, Fa P, Huang H, Ejaz A, Tsung A. Understanding the mechanism behind preoperative exercise therapy in patients with gastrointestinal cancers: a prospective randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Mar 14;17(1):50. doi: 10.1186/s13102-025-01094-6.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rubinstein, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Intervention and Physical Therapy in people with Adult Liver Carcinoma and Gastric Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty assessment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.