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Clinical Trials in China / NCT07035626
Recruiting Phase 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)

NCT07035626 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Phase 1/2
Started
2025-06-25
Last updated
2025-06-26

Condition(s) studied

Radiation-induced Xerostomia

Investigational drug(s) / intervention(s)

SpermidineSpermidine simulants

Spermidine: As a member of the polyamine family, spermidine is a trivalent cationic compound found in eukaryotic cells. It interacts with polyanions such as nucleic acids, proteins, and ATP through electrostatic binding, thereby maintaining genomic DNA stability, regulating gene transcription and translation, and modulating autophagy, apoptosis, oxidative stress, angiogenesis, and intercellular communication. Spermidine is indispensable for cell division and proliferation.

Spermidine simulants: Patients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma). 2. Aged ≥18 years and ≤80 years. 3. ECOG performance status score ≤2. 4. 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. 5. Blood routine parameters: hemoglobin ≥100 g/L, platelets ≥80×10⁹/L, white blood cell count ≥3.0×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L. 6. Signed informed consent form. Exclusion Criteria: 1. History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth. 2. Wheat allergy or gluten intolerance. 3. Suspected or confirmed physical occlusion of bilateral salivary gland ducts. 4. Prior history of head and neck radiotherapy. 5. 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. 6. Poor oral hygiene or severe periodontitis. 7. Poor compliance. 8. Pregnant or breastfeeding. 9. Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional/psychiatric disorders).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan Recruiting

More West China Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035626 on ClinicalTrials.gov ↗ ← All trials in China