Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542354
Status:
COMPLETED
Last Update Posted:
None
First Post:
2022-01-17
Brief Title:
Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy A Randomized Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is determine whether a trimodel prehabilitation program combined with physical exercise nutrition supplement and mental support during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate functional outcomes and quality of life
Detailed Description:
This study is a prospective single-center randomized control trial Including criteria were 1 Age between 18 and 80 years 2 Histologically confirmed rectal adenocarcinoma3 Performance status ECOG 0-2 4 Undergoingscheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks 5 Fried frailty score 2 Patients operated as emergency pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care All patients were treated with an ERAS protocol The primary end-point is postoperative complications within 30 days Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated The secondary end-points were functional walking capacity hospital length of stay nutrition status patient-reported health related quality of life and immune function markers The study was approved by the Ethics Committee of Zhongshan Hospital Fudan University Shanghai China Written informed consent was obtained for patients to participate the study This study followed the Consolidated Standards of Reporting Trials CONSORT reporting guideline
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care All patients were treated with an ERAS protocol The primary end-point is postoperative complications within 30 days Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated The secondary end-points were functional walking capacity hospital length of stay nutrition status patient-reported health related quality of life and immune function markers The study was approved by the Ethics Committee of Zhongshan Hospital Fudan University Shanghai China Written informed consent was obtained for patients to participate the study This study followed the Consolidated Standards of Reporting Trials CONSORT reporting guideline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None