Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2025-12-17 @ 5:10 AM
Study NCT ID:
NCT04520737
Status:
None
Last Update Posted:
2024-07-01 00:00:00
First Post:
2020-08-11 00:00:00
Brief Title:
Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Institut Investigacio Sanitaria Pere Virgili
Study Overview
Official Title:
Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
Status:
None
Status Verified Date:
2024-06
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:
PREHABMET
Brief Summary:
The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.
MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.
Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.
MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.
Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.
Detailed Description:
The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program MPP in CRLM patients which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection
MPP will consist of in-hospital high-moderate intensive exercise training nutritional assessment and high-protein supplementation smoking cessation psychological support and Comprehensive Geriatric Assessment
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test 6MWT and will be compared with patients that will follow the MPP only during the 4-weeks before surgery when preoperative CT has been finished
Secondary aims include patient reported outcomes measures such as quality of life postoperative complications length of hospital stay 30-day mortality and re-admissions Protocol feasibility will be evaluated by monitoring all interventions
MPP will consist of in-hospital high-moderate intensive exercise training nutritional assessment and high-protein supplementation smoking cessation psychological support and Comprehensive Geriatric Assessment
Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test 6MWT and will be compared with patients that will follow the MPP only during the 4-weeks before surgery when preoperative CT has been finished
Secondary aims include patient reported outcomes measures such as quality of life postoperative complications length of hospital stay 30-day mortality and re-admissions Protocol feasibility will be evaluated by monitoring all interventions
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