Radiation-induced EsophagitisPhase 2NCT07324018
Spirulina Derivative for Radiation Esophagitis
A Phase 2 study testing Hydrogel of spirulina-derived exosomes. and Radiotherapy in people with Radiation-induced Esophagitis, run by West China Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-induced Esophagitis
- What is being tested?
- Hydrogel of spirulina-derived exosomes. and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participation in other clinical trials within the past 3 months.
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a Spirulina Derivative in Preventing Radiation-Induced Esophagitis in Esophageal Cancer Patients Undergoing IMRT: A Randomized Controlled Trial
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).
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of a spirulina-derived product in reducing the incidence, duration, and severity of radiation-induced esophagitis in esophageal cancer patients. The study primarily aims to address two questions: (1) whether the spirulina-derived product can effectively prevent and mitigate radiation-induced esophageal injury, and (2) whether its use is associated with adverse events in patients undergoing intensity-modulated radiotherapy (IMRT).
Participants will be instructed to orally administer the spirulina-derived product or placebo solution four times daily, starting from the first day of radiotherapy and continuing throughout the RT course. After each administration, patients must refrain from eating, drinking, or performing oral intake for at least 1 hour to maximize mucosal contact time of the intervention.
The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related esophagitis.
- Conditions
- Radiation-induced Esophagitis
- Being tested
- Hydrogel of spirulina-derived exosomes., Hydrogel of placebo, Radiotherapy
- Keywords
- esophageal cancer, radiation-induced esophagitis, spirulina, exosome
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel of spirulina-derived exosomes.Drug
An oral hydrogel formulated with purified spirulina-derived exosomes.
Hydrogel of placeboDrug
The placebo oral hydrogel will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
RadiotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| Hydrogel of placebo | Placebo comparator | Not described Receives: Drug: Hydrogel of placebo; Radiation: Radiotherapy |
| Hydrogel of spirulina derivatives | Experimental | Not described Receives: Drug: Hydrogel of spirulina-derived exosomes.; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Toxicity Monitoring: Radiation oncologists or research nurses, uniformly trained, will assess and record the specific grade of esophagitis in patients at predefined time points, strictly adhering to the RTOG Acute Radiation Morbidity Scoring Criteria.
Start Point Determination: The date when esophagitis is first recorded as grade ≥2 during the observation period is defined as the start date of the toxicity event.
End Point Determination: The date when esophagitis is first recorded as having decreased and subsequently maintained at grade 1 or 0 in follow-up assessments is defined as the end date (i.e., recovery date) of the toxicity event.
Duration Calculation: The duration of a single event is calculated as: End Date - Start Date. If the patient's esophagitis grade has not decreased to grade 0 by the end of the observation period (8 weeks after radiotherapy completion), the duration data for that patient will be treated as censored data.
Measured: 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
Toxicity Monitoring: Radiation oncologists or research nurses, uniformly trained, will assess and record the specific grade of esophagitis in patients at predefined time points, strictly adhering to the RTOG Acute Radiation Morbidity Scoring Criteria.
Onset Point Determination: The date when esophagitis is first recorded as grade ≥2 during the observation period is defined as the onset date of this toxicity event.
Assessment Time Window: From the start of radiotherapy until 8 weeks after radiotherapy completion. To accurately capture the timing of toxicity onset, assessments are planned twice weekly during radiotherapy and once weekly during the follow-up period after radiotherapy completion.
Handling of Special Cases: If a patient has not experienced grade ≥2 esophagitis by the end of the observation period (8 weeks post-radiotherapy), the time data for this endpoint will be treated as censored data.
Measured: 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
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start12 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced EsophagitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324018
- Sponsor's protocol ID
- 2025(2393)
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Spirulina Derivative in Preventing Radiation-Induced Esophagitis in Esophageal Cancer Patients Undergoing IMRT: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07324018
- Acronym / sponsor ID
- 2025(2393)
- Conditions
- Radiation-induced Esophagitis
- Keywords
- esophageal cancer, radiation-induced esophagitis, spirulina, exosome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of a spirulina-derived product in reducing the incidence, duration, and severity of radiation-induced esophagitis in esophageal cancer patients. The study primarily aims to address two questions: (1) whether the spirulina-derived product can effectively prevent and mitigate radiation-induced esophageal injury, and (2) whether its use is associated with adverse events in patients undergoing intensity-modulated radiotherapy (IMRT).
Participants will be instructed to orally administer the spirulina-derived product or placebo solution four times daily, starting from the first day of radiotherapy and continuing throughout the RT course. After each administration, patients must refrain from eating, drinking, or performing oral intake for at least 1 hour to maximize mucosal contact time of the intervention.
The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related esophagitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogel of placebo | Placebo comparator | Drug: Hydrogel of placebo, Radiation: Radiotherapy |
| Hydrogel of spirulina derivatives | Experimental | Drug: Hydrogel of spirulina-derived exosomes., Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel of spirulina-derived exosomes.An oral hydrogel formulated with purified spirulina-derived exosomes. | Drug | Hydrogel of spirulina derivatives |
| Hydrogel of placeboThe placebo oral hydrogel will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product. | Drug | Hydrogel of placebo |
| RadiotherapyPatient 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). | Radiation | Hydrogel of placebo, Hydrogel of spirulina derivatives |
Primary outcome
The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria).
Time frame: 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.
3 secondary outcomes
Duration of Grade ≥2 Radiation Esophagitis
Time frame: 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
Time frame: 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
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogel of spirulina-derived exosomes. and Radiotherapy in people with Radiation-induced Esophagitis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (+8619382124852, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria). (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.