Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT07040969
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The longitudinal dynamics of salivary microbiota', 'timeFrame': '1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks).', 'description': '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.'}, {'measure': 'Taste function', 'timeFrame': '1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy（the last radiation dose received, usually 6 or 6.5 weeks） ; and 1, 2 months after the end of radiotherapy.', 'description': 'Taste strips test.'}, {'measure': 'Mouth and throat soreness (MTS) scores', 'timeFrame': '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.', 'description': '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'}, {'measure': 'Oral activities scores', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Longitudinal analysis of alterations in peripheral blood immune cell profiles among patients', 'timeFrame': '1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks).', 'description': 'Quantification of absolute counts and percentages of T cells, B cells, and NK cells in peripheral blood from patients.'}, {'measure': 'Xerostomia', 'timeFrame': '1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 2 months after the end of radiotherapy.', 'description': 'Xerostomia was graded per CTCAE v5.0 (Grade 1-4), with higher grades indicating worse symptoms.'}, {'measure': 'The number of patients who missed five or more consecutive radiation fractions', 'timeFrame': '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.', 'description': 'The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.'}, {'measure': 'Analysis of inflammatory Indicators in peripheral blood', 'timeFrame': '1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks).', 'description': 'Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient peripheral blood.'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Head and Neck Cancer Module (EORTC QLQ-H&N35).', 'timeFrame': '1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2 months after the end of radiotherapy.', 'description': 'European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Head and Neck Cancer Module (EORTC QLQ-H\\&N35).'}, {'measure': 'Analysis of Inflammatory Indicators in Oral Saliva', 'timeFrame': '1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks).', 'description': 'Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient oral saliva.'}], 'primaryOutcomes': [{'measure': 'The incidence of severe oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'The time to onset of severe oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.', 'description': 'Time from the first day of radiotherapy to the first determination of SOM.'}, {'measure': 'The duration of severe oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.', 'description': 'The first determination of SOM to the first instance of non-severe OM (WHO grade \\<3), without a subsequent instance of SOM.'}, {'measure': 'The incidence of any-grade oral mucositis (OM)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.', 'description': 'Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.'}, {'measure': 'The time to onset of any-grade oral mucositis (OM)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.', 'description': 'Time from the first day of radiotherapy to the first determination of OM.'}, {'measure': 'The duration of any-grade oral mucositis (OM)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.', 'description': 'The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.'}, {'measure': 'Adverse events', 'timeFrame': 'From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head &amp; neck cancer', 'Radiation-induced oral mucositis', 'spirulina', 'exosome'], 'conditions': ['Radiation-induced Oral Mucositis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;\n2. Aged ≥ 18 years;\n3. Eastern Cooperative Oncology Group performance status of ≤2;\n4. Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy;\n5. Sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with known allergy to Spirulina components or severe allergic constitution;\n2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;\n3. Poor oral hygiene and/or severe periodontal diseases;\n4. History of head and neck radiotherapy;\n5. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).'}, 'identificationModule': {'nctId': 'NCT07040969', 'briefTitle': 'Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025(1088)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Spray of placebo', 'interventionNames': ['Drug: Spray of placebo', 'Radiation: Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Spray of spirulina derivatives', 'interventionNames': ['Drug: Spray of spirulina derivatives', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Spray of spirulina derivatives', 'type': 'DRUG', 'description': 'An oral spray formulated with purified spirulina-derived exosomes.', 'armGroupLabels': ['Experimental group']}, {'name': 'Spray of placebo', 'type': 'DRUG', 'description': 'The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.', 'armGroupLabels': ['Control group']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': '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.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingchen Peng, Ph.D', 'role': 'CONTACT', 'email': 'pxx2014@163.com', 'phone': '18980606753'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Xingchen Peng, Professor', 'role': 'CONTACT', 'email': 'pxx2014@163.com', 'phone': '+8618980606753'}, {'name': 'Yiyan Pei, Doctor', 'role': 'CONTACT', 'email': 'pei_yiyan@163.com', 'phone': '+86 19382124852'}], 'overallOfficials': [{'name': 'Xingchen Peng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Xingchen Peng', 'investigatorAffiliation': 'West China Hospital'}}}}