Branched Chained Amino Acid Supplement in Patients Undergoing Lower Limb Bone Cancer Curettage for Bone Metastasis
Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Sep 18, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether taking branched-chain amino acid (BCAA) supplements after surgery can help patients who are having treatment for bone cancer in the leg. Many patients experience muscle loss after surgery, which can affect their ability to move and even swallow properly. The study aims to see if BCAA supplements taken from the first day after surgery for 30 days can reduce this muscle loss and help maintain swallowing function, as well as lower the risk of complications in the following months.
To be eligible for this trial, participants must be between 20 and 80 years old and be able to take care of themselves. They should have a specific type of bone cancer in the leg and be scheduled for surgery called curettage, which involves removing the tumor. However, people with certain health conditions or who are receiving other treatments may not qualify. If they join the study, participants will be monitored for muscle thickness and overall recovery during the first few months after their surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • I) The patient has a femoral metastasis and is expected to undergo bone tumor curettage and joint replacement surgery, or the patient has a femoral metastasis and is expected to undergo bone tumor curettage and internal fixation surgery; II) Age between 20 and 80 years; III) Able to take care of themselves independently (Karnofsky Performance Status ≥ 70%, which measures a patient's ability to perform daily activities, with a total score of 100 points. A higher score indicates better self-care ability, and a score of 70 or above indicates the ability to live independently but not to work or perform normal daily activities); IV) Patients have all signed a written informed consent.
- Exclusion Criteria:
- • I) Patients expected to undergo bone tumor curettage and mega prosthesis replacement; II) Patients requiring surgery on both upper and lower limbs; III) Patients requiring surgery on both lower limbs; IV) Patients with simultaneous spinal metastasis; V) Patients likely to undergo a second surgery within 30 days; VI) Patients with metastasis in other locations or a history of metastasis with prior surgeries; VII) Patients with neuromuscular diseases, such as stroke or Parkinson\'s disease; VIII) Exclusion of patients with other diseases and complications, such as those with concurrent gastric cancer or post-gastrectomy patients requiring additional surgeries due to complications or unstable conditions, patients with New York Heart Association Functional Classification ≥ Class 2 heart disease and thrombotic conditions, patients with Hugh-Jones Classification ≥ Grade 4 lung disease, or those currently receiving insulin therapy; IX) Patients allergic to eggs, soy, or thiamine; X) Patients who are already supplementing BCAAs; XI) Patients with psychiatric disorders that may affect their ability to provide informed consent or comply with the study protocol; XII) If postoperative pathology reveals a diagnosis other than the originally identified cancer metastasis, the case will be excluded.
About National Taiwan University Hospital
National Taiwan University Hospital (NTUH) is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a pioneer in medical education and patient care in Taiwan, NTUH integrates cutting-edge technology with comprehensive clinical expertise to facilitate groundbreaking studies across various medical fields. The hospital’s dedicated research team collaborates with local and international partners to enhance the understanding of diseases and improve treatment outcomes. By prioritizing patient safety and ethical standards, NTUH strives to contribute to the global medical community and foster advancements in healthcare practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported