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2022-06-13
2023-10-30
2023-10-30
23
NCT05225038
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
INTERVENTIONAL
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-01-10 | N/A | 2024-09-12 |
2022-01-25 | N/A | 2024-09-19 |
2022-02-04 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Control Arm (Standard of Care) Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist f | BEHAVIORAL: Behavioral Medicine
BEHAVIORAL: Smoking Cessation
|
| EXPERIMENTAL: Intervention Arm (Prehabilitation) Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens. During the data analysis, participants will be subdivided into treatment groups, | OTHER: Exercise
DIETARY_SUPPLEMENT: Nutritional
BEHAVIORAL: Behavioral Medicine
BEHAVIORAL: Smoking Cessation
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in participants physical capacity, as represented by hand grip strength | Previous studies have demonstrated that grip strength is a predictor of surgical outcomes and mortality in cancer participants. Grip strength will be measured utilizing the Jamar Dynamometer. | 3 weeks after the surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Mortality Rate | Death due to any cause postoperatively. | Up to 90 days after the surgery |
| Morbidity rate | Classified according to the Clavien-Dindo Classification of postoperative complications. | Up to 90 days after the surgery |
| Physical capacity as represented by 30s CST (Chair Stand Test ) | Participants rise to full standing position from sitting in a chair as many times as possible within 30 seconds. The 30s CST has been utilized as a reliable test of lower extremity strength. | 3 weeks after the surgery |
| Physical capacity as represented by 6-Minute Walk Test | Participants will walk as far as possible in 6 min at a comfortable pace but do not run or jog. If participants cannot complete the full 6 min walk, then record the time and distance walked and the reason for stopping early. | 3 weeks after the surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
