RecruitingPhase 2NCT07040969

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial


Sponsor

West China Hospital

Enrollment

70 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a product derived from spirulina (a type of blue-green algae) can help reduce mouth sores (oral mucositis) in patients receiving radiation therapy for head and neck cancer. Mouth sores are a painful and common side effect of radiation in this area, and this study wants to see if the spirulina product can provide relief. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a non-metastatic head and neck cancer confirmed by biopsy - You are receiving radiation therapy (60–72 Gy) with or without chemotherapy - You are in reasonably good physical condition (ECOG performance status 0–2) - You are willing to sign the consent form **You may NOT be eligible if...** - You have a known allergy to spirulina - You are currently taking antibiotics, antifungal drugs, or similar medications - You have already developed severe mouth sores before starting treatment - You have other significant conditions that would interfere with the study 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

DRUGSpray of spirulina derivatives

An oral spray formulated with purified spirulina-derived exosomes.

DRUGSpray of placebo

The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.

RADIATIONRadiotherapy

One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT07040969


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