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RECRUITING
NCT07849088
PHASE2

Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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