NCT07324018

Spirulina Derivative for Radiation Esophagitis

Efficacy of a Spirulina Derivative in Preventing Radiation-Induced Esophagitis in Esophageal Cancer Patients Undergoing IMRT: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of a Spirulina-derived product in preventing and treating radiation-induced esophagitis in esophageal cancer patients undergoing intensity-modulated radiotherapy (IMRT).

Detailed description

The goal of this clinical trial is to evaluate the efficacy and safety of a spirulina-derived product in reducing the incidence, duration, and severity of radiation-induced esophagitis in esophageal cancer patients. The study primarily aims to address two questions: (1) whether the spirulina-derived product can effectively prevent and mitigate radiation-induced esophageal injury, and (2) whether its use is associated with adverse events in patients undergoing intensity-modulated radiotherapy (IMRT). Participants will be instructed to orally administer the spirulina-derived product or placebo solution four times daily, starting from the first day of radiotherapy and continuing throughout the RT course. After each administration, patients must refrain from eating, drinking, or performing oral intake 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 esophagitis.

Conditions

• Radiation-induced Esophagitis

Interventions

Type	Name	Description
DRUG	Hydrogel of spirulina-derived exosomes.	An oral hydrogel formulated with purified spirulina-derived exosomes.
DRUG	Hydrogel of placebo	The placebo oral hydrogel will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
RADIATION	Radiotherapy	Patient eligibility was defined as a diagnosis of esophageal cancer with a treatment plan involving radiotherapy (radiotherapy alone or concurrent chemoradiotherapy) using intensity-modulated radiotherapy (IMRT).

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2026-01-07
• Last updated: 2026-01-08

Locations

1 site across 1 country: China