Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602026
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2020-10-20
Brief Title:
The RIOT Trial Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic Liver or Gastric Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Re-Defining Frailty and Improving Outcomes Through Prehabilitation RIOT Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIOT
Brief 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 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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-04925 | REGISTRY | CTRP Clinical Trial Reporting Program | None |