BCAA in Patients Undergoing Gastric Cancer Surgery

NCT06340399 | Not Yet Recruiting

• 1 other identifier: 202312117RINE
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perioeprative Muscle Loss

Outcome Measures

Primary Outcomes (1)

• the occurrence of surgical related muscle loss

  examined the surgical related muscle loss occurence

  before surgery to postoperative day 7

Study Arms (2)

patients receiving BCAA

EXPERIMENTAL

patients undergoing BCAA before surgery to postoperative day 30

Dietary Supplement: BCAA

patients not receiving BCAA

PLACEBO COMPARATOR

patient not undergoing BCAA

Other: patient not administered BCAA

Interventions

BCAA DIETARY_SUPPLEMENT

patients administering BCAA

patients receiving BCAA

patient not administered BCAA OTHER

patients not administered BCAA

patients not receiving BCAA

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I) Patients confirmed to have gastric adenocarcinoma (one type of stomach cancer) through endoscopic biopsy prior to surgery, with the selection based on this type representing the majority of gastric cancer cases at National Taiwan University Hospital.
• III) Severity of gastric cancer: Patients with clinical stages I to III and no distant metastasis, undergoing complete tumor resection, according to the 15th edition of the Japanese Gastric Cancer Classification.
• IV) Postoperative status assessment of patients: Utilizing the Eastern Cooperative Oncology Group (ECOG) scoring system to assess the performance status of cancer patients. Scores of 0-2 indicate relatively good overall health, normal daily activities, and the ability to tolerate cancer-related treatments.
• V) Patients with normal general blood biochemistry values, including Aspartate Aminotransferase (AST), Alanine aminotransferase (ALT), Total Bilirubin, and Creatinine.
• VI) Patients provide written informed consent prior to participation.

You may not qualify if:

• II) Patients taking preventive medication for gastric cancer, such as those undergoing treatment for Helicobacter pylori infection.
• III) As this study involves preoperative and postoperative rehabilitation exercises, patients with impaired physical function are not suitable.
• IV) Individuals allergic to eggs, soybeans, or thiamine.
• V) Patients already supplementing with BCAA (branched-chain amino acids).
• VI) Individuals with psychological disorders that may affect their ability to provide informed consent or adhere to the study protocol.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Central Study Contacts

Chih-Jun Lai

CONTACT

_886-972652086; littlecherrytw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: this is a open label use study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: patients receiving BCAA

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share