Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT07040969
Brief 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.
Detailed Description:
The goal of this clinical trial is to evaluate the efficacy and safety of spirulina-derived product in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The study primarily aims to address two questions: (1) whether spirulina-derived product can effectively prevent and mitigate radiation-induced oral mucositis, and (2) whether its use is associated with adverse events in patients undergoing radiotherapy.
Participants will be instructed to orally administer the spirulina-derived product or placebo spray four times daily, starting from the first day of radiotherapy (RT) and continuing throughout the RT course. After each spray application, patients must refrain from eating, drinking, or performing oral hygiene activities for at least 1 hour to maximize mucosal contact time of the intervention.
The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related oral mucositis.
Study:
NCT07040969
Study Brief:
Protocol Section:
NCT07040969