MedTrace Logo

The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa

NCT07723612 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-23

No results posted yet for this study

Summary

This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of spirulina supplementation in patients with radiation-induced oral mucositis (RIOM) receiving radiotherapy for head and neck cancer. Participants will be randomly assigned to receive either spirulina tablets or placebo in addition to standard oral care during radiotherapy. The primary objective is to determine whether spirulina reduces the severity of oral mucositis. Secondary outcomes include the incidence and duration of severe oral mucositis, oral pain, nutritional status, quality of life, treatment interruption, and adverse events. The findings of this study may provide evidence for an effective and safe adjunctive intervention to improve the management of radiation-induced oral mucositis and enhance the quality of life of patients undergoing radiotherapy.

Conditions

  • Recurrent Aphthous Stomatitis
  • Mouth Ulcer

Interventions

DIETARY_SUPPLEMENT

Spirulina Tablets

Spirulina tablets will be administered at a dose of 3 g/day (6 tablets daily) from the first day of radiotherapy until completion of radiotherapy.

OTHER

Placebo Tablets

Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.

Sponsors & Collaborators

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Xu Huang, PhD · The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-07-01
Completion
2028-07-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07723612 on ClinicalTrials.gov