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BCAA in Patients Undergoing Gastric Cancer Surgery
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
- - 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.
II) Patients aged between 20 and 90, irrespective of gender, are eligible for inclusion. 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.Exclusion Criteria:
- - 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.
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.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: patients receiving BCAA
patients undergoing BCAA before surgery to postoperative day 30
Placebo Comparator: patients not receiving BCAA
patient not undergoing BCAA
Interventions
Dietary Supplement: - BCAA
patients administering BCAA
Other: - patient not administered BCAA
patients not administered BCAA
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Chih-Jun Lai
[email protected]
_886-972652086
For additional contact information, you can also visit the trial on clinicaltrials.gov.
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