Spirulina Derivative for Radiation Esophagitis
NCT07324018 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-01-08
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).
Conditions
- Radiation-induced Esophagitis
Interventions
- 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).
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-12
- Primary Completion
- 2026-06-30
- Completion
- 2026-08-31
Countries
- China
Study Locations
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