Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340399
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
BCAA in Patients Undergoing Gastric Cancer Surgery
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Impact of Oral Branched-Chain Amino Acids Under Enhanced Recovery After Surgery on Reducing Postoperative Muscle Loss Swallowing Difficulties and Complications After Gastric Cancer Surgery From Clinical to Precision Nutrition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Older patients undergoing gastric cancer resection at higher risk due to insufficient preoperative muscle mass are more susceptible to SRML under surgical stress This not only affects limb muscles but also impacts swallowing muscles contributing to increased postoperative complications and mortality rates Enhanced Recovery After Surgery ERAS has emerged as a multidisciplinary approach to facilitate postoperative recovery This study aims to optimize oral nutrition under the ERAS model to observe its impact on SRML BCAA is essential for skeletal muscles However there is limited research on the oral BCAA whether before or after surgery concerning SRML and its associated complications The study entails an 18-month randomized controlled trial with 200 participants One hundred individuals will take BCAA daily 5 to 14 days before surgery After surgery they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively The other one hundred participants will not receive BCAA The study aims to investigate whether oral BCAA can reduce SRML muscle loss and decrease swallowing muscle strength with observations on postoperative complications and outcomes within one year
Detailed Description:
Surgical Related Muscle Loss SRML is a prevalent complication following surgery defined by a 10 percent or more reduction in muscle mass in at least one arm and one leg muscle by the seventh day postoperatively Older patients undergoing gastric cancer resection at higher risk due to insufficient preoperative muscle mass are more susceptible to SRML under surgical stress This not only affects limb muscles but also impacts swallowing muscles contributing to increased postoperative complications and mortality rates Enhanced Recovery After Surgery ERAS has emerged as a multidisciplinary approach to facilitate postoperative recovery This study aims to optimize oral nutrition under the ERAS model to observe its impact on SRML BCAA is essential for skeletal muscles However there is limited research on the oral BCAA whether before or after surgery concerning SRML and its associated complications
The investigators entails an 18-month randomized controlled trial with 200 participants One hundred individuals will take 3160 mg of BCAA daily 14 days before surgery After surgery they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively The other one hundred participants will not receive BCAA The study aims to investigate whether oral BCAA can reduce SRML muscle loss and decrease swallowing muscle strength with observations on postoperative complications and outcomes within one year
Regarding the swallowing measurement high-resolution impedance manometry the most accurate tool for assessing swallowing muscle strength will be used The ultrasound will also be used to investiagte the muscle loss We will also investigate the genome associated BCAA study
The investigators entails an 18-month randomized controlled trial with 200 participants One hundred individuals will take 3160 mg of BCAA daily 14 days before surgery After surgery they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively The other one hundred participants will not receive BCAA The study aims to investigate whether oral BCAA can reduce SRML muscle loss and decrease swallowing muscle strength with observations on postoperative complications and outcomes within one year
Regarding the swallowing measurement high-resolution impedance manometry the most accurate tool for assessing swallowing muscle strength will be used The ultrasound will also be used to investiagte the muscle loss We will also investigate the genome associated BCAA study
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