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Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury
Sponsor: Peking University First Hospital
Summary
This prospective randomized controlled study evaluates the clinical efficacy of modified Zhixiao Tongmai Ning in preventing radiation-induced kidney injury in cancer patients. We will assess improvements using routine lab indicators (e.g., glomerular filtration rate, serum creatinine, urine tests), Traditional Chinese Medicine (TCM) syndrome criteria, patient-reported scores, and renal dynamic imaging. The study aims to identify the most suitable patient subgroups and optimal timing for drug use by analyzing baseline factors, radiation parameters, and concurrent treatments, thereby optimizing the formula. Additionally, we will collect blood and urine samples to explore potential mechanisms, focusing on inflammatory factors like TNF-α and IL-6, to support future basic research and clinical application.
Official title: Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury in Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2026-08-11
Completion Date
2029-06-01
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
Modified Zhixiao Tongmai Ning
Patients will receive modified Zhixiao Tongmai Ning (a Traditional Chinese Medicine formula for clearing heat and nourishing Yin) orally, twice daily, throughout the course of radiotherapy and the follow-up period. The administration is combined with kidney-sparing radical radiotherapy for renal malignancies. The specific dosage will be adjusted based on individual TCM syndrome differentiation and clinical condition.
Standard Radiotherapy Alone
Patients will receive standard care or a matching placebo orally, twice daily, throughout the course of radiotherapy and the follow-up period, combined with the same kidney-sparing radical radiotherapy for renal malignancies.
Locations (1)
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, Beijing Municipality, China