Seaweed shield: spirulina derivative tested to stop radiation burns in throat
NCT ID NCT07324018
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a product made from spirulina (a type of algae) can prevent severe throat pain caused by radiation therapy in people with esophageal cancer. About 70 patients will receive either the spirulina derivative or a placebo during their radiation treatments. The goal is to see if the supplement reduces the number of patients who develop moderate to severe esophagitis (inflammation of the food pipe).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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