RecruitingPhase 1Phase 2NCT07035626

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


Sponsor

West China Hospital

Enrollment

58 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a supplement called spermidine can prevent or reduce dry mouth (called xerostomia) — a common and debilitating side effect of radiation therapy — in people being treated for head and neck cancer or nasopharyngeal carcinoma (a cancer at the back of the nose/throat). **You may be eligible if...** - You have a confirmed diagnosis of head and neck squamous cell carcinoma or nasopharyngeal carcinoma - You are between 18 and 80 years old - You are receiving radical radiotherapy or concurrent chemoradiotherapy with a radiation dose greater than 50 Gy - Your radiation plan means your salivary glands (parotid glands) will receive significant radiation - Your blood counts are within acceptable ranges **You may NOT be eligible if...** - You are not receiving the required level of radiation to the salivary glands - You have significant low blood counts - You have already developed severe dry mouth prior to treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpermidine

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.

DRUGSpermidine 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

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NCT07035626


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