Overview
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.
Description
This prospective randomized controlled trial comprehensively evaluates the efficacy of modified Zhixiao Tongmai Ning for preventing radiation-induced kidney injury. Assessments combine routine labs (GFR, creatinine, urinalysis), TCM syndrome criteria, patient-reported scores, and pioneering renal dynamic bilateral renal function imaging for precise multi-dimensional evaluation.
Subgroup analyses based on baseline factors (age, gender, renal function, comorbidities), radiotherapy parameters (fractionation, DVH), and anti-tumor treatments will identify optimal patient subgroups and drug timing, supporting formula optimization and component purification.
Additionally, pre- and post-treatment blood and urine samples will be collected to analyze pro-inflammatory cytokines (TNF-α, IL-6). This explores the heat-clearing and Yin-nourishing mechanism against radiation injury, establishing a basis for future animal models and deep mechanistic research.
Eligibility
Inclusion Criteria:
- Histologically or clinically confirmed renal malignancy scheduled to receive kidney-sparing radical radiotherapy.
- Baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² and serum creatinine within normal limits.
- Expected survival of at least 6 months and able to comply with the study protocol and follow-up visits.
- Provision of written informed consent prior to any study-related procedures.
Exclusion Criteria:
- Pre-existing severe renal impairment (e.g., estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m²) or history of renal failure.
- Known allergy or hypersensitivity to any components of Zhixiao Tongmai Ning or other Traditional Chinese Medicine herbs.
- Previous treatment with nephrotoxic agents within 4 weeks prior to enrollment, or bilateral renal involvement making kidney-sparing radiotherapy unfeasible.
- Presence of severe uncontrolled systemic diseases (e.g., severe cardiovascular disease, active infection) or expected survival of less than 6 moPregnant or breastfeeding women, or patients with poor compliance who are unable to complete the required follow-up visits.nths.
