Not Yet RecruitingPhase 2

Spirulina Derivative for Radiation Esophagitis

China70 participantsStarted 2026-01-12

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with histopathologically confirmed malignant esophageal tumor and no distant metastasis;
✓. Age ≥ 18 years;
✓. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2;
✓. Scheduled to undergo definitive radiotherapy, neoadjuvant radiotherapy, or adjuvant radiotherapy for esophageal cancer;
✓. Adequate hepatic, renal, and bone marrow function;
✓. Signed informed consent form.

Exclusion criteria

✕. History of prior thoracic radiotherapy.
✕. Known allergy to spirulina or its derivatives, any component of the thermosensitive gel, or having a history of severe allergic predisposition.
✕. Presence of esophageal or oral diseases assessed by the investigator before radiotherapy initiation that may affect the analysis of this study's results (e.g., reflux esophagitis, Barrett's esophagus, severe oral infection, recurrent aphthous ulcers, oral lichen planus, etc.).
✕. Use of systemic antibacterial or antifungal medications within one week prior to the start of radiotherapy.
✕. Planned concurrent use of medications that may exacerbate radiation-induced mucosal injury after radiotherapy initiation (e.g., anti-EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.).
✕. Presence of severe underlying diseases of the cardiovascular, pulmonary, hepatic, renal, hematopoietic, or nervous systems (specific criteria for organ dysfunction are detailed in item 7 below), or conditions such as acute infection, uncontrolled autoimmune diseases, poorly controlled diabetes mellitus, etc., which, in the investigator's judgment, may increase study risks or interfere with result analysis.
✕. Presence of significant organ dysfunction meeting any of the following criteria:
✕. Pregnant or lactating women.

What they're measuring

The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria).

Timeframe: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.

Trial details

NCT IDNCT07324018

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Xingchen Peng

+8619382124852 pxx2014@163.com

View on ClinicalTrials.gov More Radiation-induced Esophagitis trials