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NCT06340399Not yet recruiting

BCAA in Patients Undergoing Gastric Cancer Surgery

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
25 Mar 2024
Start date
28 Mar 2024
Primary completion date
31 Dec 2029
Lead sponsor
National Taiwan University Hospital
NCT number
NCT06340399

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 28 Mar 2024 to the primary completion date, 31 Dec 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \- I) Exclusion criteria include patients with other diseases and complications such as: concurrent cancers in the stomach, the need for additional surgeries due to postoperative complications or unstable conditions, heart diseases categorized as New York Heart Association functional class ≥2 with thrombotic conditions, lung diseases categorized as Hugh-Jones grade ≥4, and patients currently undergoing insulin therapy.

Other illness

  • Patients taking preventive medication for gastric cancer, such as those undergoing treatment for Helicobacter pylori infection.
  • Individuals allergic to eggs, soybeans, or thiamine.
  • Individuals with psychological disorders that may affect their ability to provide informed consent or adhere to the study protocol.

Other

  • As this study involves preoperative and postoperative rehabilitation exercises, patients with impaired physical function are not suitable.
  • Patients already supplementing with BCAA (branched-chain amino acids).

Who the study is looking for

  • 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.
  • Patients aged between 20 and 90, irrespective of gender, are eligible for inclusion.
  • 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.
  • 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.
  • Patients with normal general blood biochemistry values, including Aspartate Aminotransferase (AST), Alanine aminotransferase (ALT), Total Bilirubin, and Creatinine.
  • Patients provide written informed consent prior to participation.

Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.