Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565052
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer The PROPEL Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer The PROPEL Trial
Status:
NOT_YET_RECRUITING
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 to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy andor radiation followed by surgical resection
The names of the groups in this research study are
Group A Prehabilitation program
Group B Usual Care
The names of the groups in this research study are
Group A Prehabilitation program
Group B Usual Care
Detailed Description:
This is a non-blinded randomized control trial to determine the feasibility of a hybrid-model prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy chemotherapy andor radiation before surgical resection Investigators hope that prehabilitation will result in improved outcomes after surgery
Participants will be randomized into one of the study groups Group A prehabilitation program or Group B usual care Randomization means that a participant is placed into a group by chance
The research study procedures include screening for eligibility in-clinic visits physical exams exercise training blood tests and questionnaires
It is expected that about 40 participants will take part in this research study
Participants will be randomized into one of the study groups Group A prehabilitation program or Group B usual care Randomization means that a participant is placed into a group by chance
The research study procedures include screening for eligibility in-clinic visits physical exams exercise training blood tests and questionnaires
It is expected that about 40 participants will take part in this research study
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