Mouth Ulcer, Recurrent Aphthous Stomatitis
Conditions
Keywords
Radiation-induced oral mucositis Recurrent aphthous stomatitis Oral ulcer Spirulina Oral microbiota Saliva biomarkers Supportive care
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.
Detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating spirulina as an adjunctive intervention for radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancer. Radiation-induced oral mucositis is a common and clinically significant adverse effect of radiotherapy. It may cause oral pain, difficulty eating and swallowing, nutritional deterioration, reduced quality of life, and interruption of anticancer treatment. Current management is mainly supportive, and additional safe and effective interventions are needed. Eligible participants will be randomized to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy. The study will compare the effects of spirulina and placebo on the severity, incidence, and duration of oral mucositis. Oral pain, nutritional status, quality of life, treatment compliance, radiotherapy interruption, and adverse events will also be evaluated. The purpose of this trial is to determine whether spirulina supplementation can reduce the burden of radiation-induced oral mucositis and improve supportive care for patients undergoing radiotherapy. The safety of spirulina will be monitored throughout the study.
Interventions
DIETARY_SUPPLEMENTSpirulina 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.
OTHERPlacebo Tablets
Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and investigators will be blinded to group assignment. Participants will receive either spirulina tablets or matching placebo tablets in addition to standard oral care during radiotherapy.
Intervention model description
Participants will be randomly assigned in parallel to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Clinical Characteristics of Oral Mucosal Ulcers | From Day 0 (before intervention) through Day 14, assessed daily. | The incidence and clinical characteristics of oral mucosal ulcers were assessed by standardized oral examinations. The number, location, maximum diameter, estimated ulcer area, erythema, pseudomembrane or exudate, and clinical severity of ulcers were recorded throughout the study. |
| Oral Pain Intensity (Visual Analog Scale, VAS) | Day 0 (before intervention), Day 7, and Day 14. | Oral pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity. |
| Oral Microbiota Composition | Day 0 (before intervention), Day 7, and Day 14. | Oral microbiota samples were collected for metagenomic sequencing to evaluate changes in microbial composition, microbial diversity, and relative abundance following the intervention. |
| Salivary Biomarkers | Day 0 (before intervention), Day 7, and Day 14. | Unstimulated saliva samples were collected to measure inflammatory and oxidative stress biomarkers, including IL-6, TNF-α, MDA, and SOD, to evaluate the biological effects of the intervention. |
Countries
China
Contacts
CONTACTHaijiao Zhao, Master's Student
PRINCIPAL_INVESTIGATORXu Huang, PhD
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed