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To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
The goal of this clinical trial is to evaluate the efficacy and safety of spirulina-derived product in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The study primarily aims to address two questions: (1) whether spirulina-derived product can effectively prevent and mitigate radiation-induced oral mucositis, and (2) whether its use is associated with adverse events in patients undergoing radiotherapy.
Participants will be instructed to orally administer the spirulina-derived product or placebo spray four times daily, starting from the first day of radiotherapy (RT) and continuing throughout the RT course. After each spray application, patients must refrain from eating, drinking, or performing oral hygiene activities 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 oral mucositis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Spray of placebo |
|
| Experimental group | Experimental | Spray of spirulina derivatives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spray of spirulina derivatives | Drug | An oral spray formulated with purified spirulina-derived exosomes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe oral mucositis (WHO grade ≥3) | Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The time to onset of severe oral mucositis (WHO grade ≥3) | Time from the first day of radiotherapy to the first determination of SOM. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| The duration of severe oral mucositis (WHO grade ≥3) |
| Measure | Description | Time Frame |
|---|---|---|
| The longitudinal dynamics of salivary microbiota | Unstimulated whole saliva samples will be collected via spitting method at three time points: baseline, mid-term radiotherapy (the week corresponding to 50% completion of the planned radiation fractions), and the end of radiotherapy (the final week of RT). 16S rRNA gene sequencing will be performed to assess alterations in the oral microbiota. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng, Professor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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| Spray of placebo | Drug | The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product. |
|
| Radiotherapy | Radiation | One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy. |
|
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. |
| From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| The incidence of any-grade oral mucositis (OM) | Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| The time to onset of any-grade oral mucositis (OM) | Time from the first day of radiotherapy to the first determination of OM. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| The duration of any-grade oral mucositis (OM) | The first determination of OM to the first instance of non-OM, without a subsequent instance of OM. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Adverse events | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Taste function | Taste strips test. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Mouth and throat soreness (MTS) scores | Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Oral activities scores | Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms. | The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Longitudinal analysis of alterations in peripheral blood immune cell profiles among patients | Quantification of absolute counts and percentages of T cells, B cells, and NK cells in peripheral blood from patients. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Xerostomia | Xerostomia was graded per CTCAE v5.0 (Grade 1-4), with higher grades indicating worse symptoms. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| The number of patients who missed five or more consecutive radiation fractions | The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Analysis of inflammatory Indicators in peripheral blood | Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient peripheral blood. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Analysis of Inflammatory Indicators in Oral Saliva | Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient oral saliva. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Overall Health Status and Core Dimensions of Quality of Life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden. | From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks. |
| Head and Neck Cancer-Specific Symptoms | The EORTC QLQ-H&N35 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with head and neck cancer. It comprises 35 items, organized into seven multi-item subscales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single-item measures (such as dental problems, problems opening mouth, sticky saliva, coughing, etc.). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm. Interpretation of Scores: For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden. | From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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