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NCT07723612

Overview

NCT ID: NCT07723612
Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineOTHER
Official Title: The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jun 1, 2026Actual
Primary Completion Date: Jul 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults aged 18 years or older.

Patients with radiation-induced oral mucositis (RIOM), recurrent aphthous stomatitis (RAS), or other clinically diagnosed oral ulcers, confirmed by clinical examination.

Presence of at least one clinically active oral ulcer at the time of enrollment.

Able to understand the study procedures and provide written informed consent.

Willing and able to comply with all study procedures, follow-up visits, and assessments.

Exclusion Criteria:

Previous radiotherapy to the head and neck region.

Known allergy or hypersensitivity to spirulina or its components.

Severe hepatic, renal, cardiovascular, or other uncontrolled systemic diseases.

Pregnancy or breastfeeding.

Participation in another interventional clinical trial during the study period.

Any condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Haijiao Zhao, Master's StudentContact
zhaohaijiao@zju.edu.cn13858107163

Similar Studies

Participant Group/Arms

Spirulina GroupExperimental

Participants will receive spirulina tablets (3 g/day, 6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy.

Dietary Supplement: Spirulina Tablets

Placebo GroupPlacebo Comparator

Participants will receive matching placebo tablets (6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy.

Other: Placebo Tablets