Actively Recruiting
A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
Led by West China Hospital · Updated on 2025-06-26
58
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, double-blind, randomized controlled clinical trial with placebo as the control, aiming to evaluate the effectiveness of spermidine in preventing radiation-induced xerostomia during radiotherapy for head and neck tumors (including nasopharyngeal carcinoma).
CONDITIONS
Official Title
A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed head and neck squamous cell carcinoma, including nasopharyngeal carcinoma
- Aged 18 to 80 years
- ECOG performance status score 2 or less
- Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose over 50 Gy, with specified parotid gland dose criteria
- Blood parameters within required ranges: hemoglobin ≥100 g/L, platelets ≥80×10⁹/L, white blood cell count ≥3.0×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L
- Signed informed consent form
You will not qualify if you...
- History of dry mouth, Sjögren's syndrome, or other systemic diseases causing dry mouth
- Wheat allergy or gluten intolerance
- Suspected or confirmed blockage of both salivary gland ducts
- Previous head and neck radiotherapy
- Use of medications or supplements affecting salivary function within past 30 days or planned use during study
- Poor oral hygiene or severe periodontitis
- Poor compliance
- Pregnant or breastfeeding
- Other conditions deemed unsuitable by the investigator, including severe comorbidities or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
X
Xingchen Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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