A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in… (NCT07035626) | Clinical Trial Compass
RecruitingPhase 1/2
A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
China58 participantsStarted 2025-06-25
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
✓. Aged ≥18 years and ≤80 years.
✓. ECOG performance status score ≤2.
✓. Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose \>50 Gy, where: Both parotid glands receive an average dose ≥25 Gy; or one gland receives a dose ≥25 Gy and the other receives any dose.
✕. History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.
✕. Wheat allergy or gluten intolerance.
✕. Suspected or confirmed physical occlusion of bilateral salivary gland ducts.
✕. Prior history of head and neck radiotherapy.
✕. Use of any medications or herbal supplements that may affect salivary function within the past 30 days, or planned/final use during the study period (e.g., amifostine, cholinergic agonists \[pilocarpine, cevimeline\], certain β-adrenergic antagonists, anticholinergic drugs, or other known salivary function modifiers). If using saliva substitutes, patients must abstain from use for at least 24 hours prior to saliva and questionnaire data collection.
What they're measuring
1
Radiation-induced xerostomia
Timeframe: Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.