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

NCT07040969 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Radiation-induced Oral Mucositis

Interventions

DRUG

Spray of spirulina derivatives

An oral spray formulated with purified spirulina-derived exosomes.

DRUG

Spray of placebo

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

RADIATION

Radiotherapy

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng, Professor · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-01-15
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040969 on ClinicalTrials.gov