Spirulina Derivative for Radiation Esophagitis

NCT07324018 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025(2393)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

esophageal cancer; radiation-induced esophagitis; spirulina; exosome

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (3)

• Duration of Grade ≥2 Radiation Esophagitis

  From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.

• Time to Onset of Grade ≥2 Esophagitis

  From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.

• Adverse events

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

Other Outcomes (3)

• The longitudinal dynamics of salivary microbiota

  From the start of radiotherapy (baseline) to treatment completion. The total evaluation period is approximately 6 to 6.5 weeks.

• Overall Health Status and Core Dimensions of Quality of Life

  From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.

• Esophageal Cancer-Specific Symptoms

  From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.

Study Arms (2)

Hydrogel of placebo

PLACEBO COMPARATOR

Drug: Hydrogel of placebo; Radiation: Radiotherapy

Hydrogel of spirulina derivatives

EXPERIMENTAL

Drug: Hydrogel of spirulina-derived exosomes.; Radiation: Radiotherapy

Interventions

Hydrogel of spirulina-derived exosomes. DRUG

An oral hydrogel formulated with purified spirulina-derived exosomes.

Hydrogel of spirulina derivatives

Hydrogel of placebo DRUG

The placebo oral hydrogel will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.

Hydrogel of placebo

Radiotherapy RADIATION

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).

Hydrogel of placebo; Hydrogel of spirulina derivatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• Pregnant or lactating women.
• History of severe mental illness, alcohol abuse, or drug abuse.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xingchen Peng

CONTACT

+8619382124852; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 7, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)