At a glance
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Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Spray of spirulina derivatives, Spray of placebo, and 1 other intervention for Radiation-induced Oral Mucositis. Active but no longer recruiting, targeting 70 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
An oral spray formulated with purified spirulina-derived exosomes.
The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
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.