NCT07035626

A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). The experimental group took spermidine capsules twice a day with meals, while the placebo group took placebo capsules twice a day with meals. The appearance and taste of the placebo and spermidine were kept the same. The primary end point was radiation-induced xerostomia, as determined by the Xerostomia Questionnaire in which a higher score indicates worse radiation-induced xerostomia.

Conditions

• Radiation-induced Xerostomia

Interventions

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

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-06-08
• Completion: 2026-06-08
• First posted: 2025-06-25
• Last updated: 2025-06-26

Locations

1 site across 1 country: China