Hydrogel of spirulina-derived exosomes.Hydrogel of placeboRadiotherapy
Hydrogel of spirulina-derived exosomes.: An oral hydrogel formulated with purified spirulina-derived exosomes.
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.
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).
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with histopathologically confirmed malignant esophageal tumor and no distant metastasis;
2. Age ≥ 18 years;
3. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2;
4. Scheduled to undergo definitive radiotherapy, neoadjuvant radiotherapy, or adjuvant radiotherapy for esophageal cancer;
5. Adequate hepatic, renal, and bone marrow function;
6. Signed informed consent form.
Exclusion Criteria:
1. History of prior thoracic radiotherapy.
2. Known allergy to spirulina or its derivatives, any component of the thermosensitive gel, or having a history of severe allergic predisposition.
3. 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.).
4. Use of systemic antibacterial or antifungal medications within one week prior to the start of radiotherapy.
5. 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.).
6. 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.
7. Presence of significant organ dysfunction meeting any of the following criteria:
* Hemoglobin \< 80 g/L;
* Neutrophil count \< 1.0 × 10⁹/L;
* Platelet count \< 80 × 10⁹/L;
* Serum total bilirubin ≥ 2 times the upper limit of normal (ULN);
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times ULN;
* Serum creatinine \> 1.5 times ULN.
8. Pregnant or lactating women.
9. History of severe mental illness, alcohol abuse, or drug abuse.
10. Participation in other clinical trials within the past 3 months.
11. Any other condition deemed by the investigator as potentially rendering the subject unsuitable for participation in this study (e.g., extremely poor oral hygiene, poor compliance, etc.).
Primary outcome measure(s)
The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria). — From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks. Radiation esophagitis is assessed by trained radiotherapists according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. The RTOG criteria categorize acute esophageal toxicity into grades 0-4, with a higher grade indicating more severe symptoms. Grade 0 represents no change over baseline; grade 1 represents mild dysphagia or odynophagia requiring topical anesthetic or non-narcotic analgesics/soft diet; grade 2 represents moderate dysphagia or odynophagia requiring narcotic analgesics/pureed or liquid diet; grade 3 represents severe dysphagia or odynophagia with dehydration or weight loss (\>15% from pre-treatment baseline) requiring nasogastric feeding tube, intravenous fluids, or hyperalimentation; and grade 4 represents complete obstruction, ulceration, perforation, or fistula formation.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.