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RECRUITING
NCT07035626
PHASE1/PHASE2

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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).

Official title: A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2025-06-25

Completion Date

2026-06-08

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

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.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China