Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604910
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Branched Chained Amino Acid Supplement in Patients Undergoing Lower Limb Bone Cancer Curettage for Bone Metastasis
Sponsor:
None
Organization:
None
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 Lower Limb Bone Cancer Curettage for Bone Metastasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Postoperative muscle loss is common in patients with bone metastases undergoing lower limb bone cancer curettage affecting both limb skeletal muscles and potentially swallowing-related muscles Rectus femoris thickness measured via ultrasound on postoperative day seven is used to assess this loss Branched-chain amino acids BCAAs are important for muscle protein synthesis but little research exists on whether postoperative oral BCAA supplementation can reduce muscle loss swallowing function deterioration and short-term complications This study investigates if BCAA supplementation from postoperative day one to day 30 can reduce muscle loss primary endpoint rectus femoris thickness on day seven and mitigate swallowing function decline pharyngeal muscle contraction loss and complications within three months post-surgery
Detailed Description:
Postoperative muscle loss is common in patients with bone metastases undergoing lower limb bone cancer curettage affecting both limb skeletal and swallowing-related muscles with rectus femoris thickness measured via ultrasound on postoperative day seven Branched-chain amino acids BCAAs are crucial for muscle protein synthesis but limited research exists on whether postoperative oral BCAA supplementation can reduce muscle loss swallowing function deterioration and short-term complications within three months This study aims to determine if BCAA administration from postoperative day one to day 30 can reduce muscle loss with rectus femoris thickness on day seven as the primary endpoint while also exploring the effect on swallowing function pharyngeal muscle strength and complication rates It will target patients with lower limb bone metastases from breast lung and prostate cancers excluding those with high mortality risk or metastases in other regions In a one-year randomized controlled trial 40 patients will be assigned to receive either 3160 mg of daily BCAA for 30 days or no supplementation Primary outcomes include rectus femoris muscle thickness and swallowing muscle strength assessed by high-resolution manometry with postoperative complications followed for three months The expected result is that the BCAA group will experience less muscle loss greater rectus femoris thickness reduced swallowing muscle decline and fewer complications This study aims to improve care quality promote recovery and support sustainable health goals
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