Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT03932292
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2019-04-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician', 'timeFrame': 'Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (28 days after the last RT)', 'description': 'The degree of oral mucositis will be assessed as follow: grade 0, no signs or symptoms; grade 1, oral soreness and erythema; grade 2, oral erythema, ulcers and solid diet tolerated; grade 3, oral ulcers and liquid diet only; grade 4, oral alimentation impossible'}, {'measure': 'Change in mucositis symptoms dry mucosa, irritation of mucosa, coated tongue, unpleasant breath, decreased saliva release, pain, swelling, ulcer, difficulty to speak and difficulty to eat and dring by using a Numeric Rating Scale', 'timeFrame': 'day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)', 'description': 'Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).'}], 'secondaryOutcomes': [{'measure': 'Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)', 'timeFrame': 'within 28 days after starting radiotherapy', 'description': 'All occuring adverse events/serious adverse events will be documented during the entire study period.'}, {'measure': 'Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)', 'timeFrame': 'Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (after 28 days after the last RT)', 'description': "The KPS index allows patients to be classified as to their functional impairment and describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no symptoms) to 0% (death)."}, {'measure': 'Tolerability assessment by using a subsequent patient questionnaire', 'timeFrame': 'day 28', 'description': 'The following score system will be used to quantify these evaluation: "very good" = 4; "good" =3; "neither good nor bad" = 2; "bad" = 1 and "very bad" = 0.'}, {'measure': 'Satisfaction assessed by a subsequent patient questionnaire', 'timeFrame': 'day 28', 'description': 'The following score system will be used to quantify these evaluation: "yes" 2; "maybe" = 1; and "no" = 0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ectoin', 'Oral mucositis', 'Radiotherapy', 'Medical Device', 'Non interventional study', 'Mouth Wash', '§23b Medical Device Act'], 'conditions': ['Oral Mucositis Due to Radiation']}, 'descriptionModule': {'briefSummary': 'This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals regardless of gender older than 18 years\n* Patients diagnosed with squamous cell carcinomas \\[SCCHN\\] without metastases of other nonhead and nonneck tumors\n* Patients receiving radiotherapy with a Karnofsky performance index \\>70%\n* Absence of any sign of oral mucositis at baseline (visit 1)\n* A definitive or postoperative treatment\n* Radiation therapy dosage: Limitation dose rate of 60-70 Gy\n* Radiotherapy of 6-7 weeks duration\n\nExclusion Criteria:\n\n* Subjects younger than 18 years\n* Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash\n* Pregnancy or breastfeeding women\n* Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial\n* Patients who had a history of previous radiotherapy in head-neck region or chemotherapy\n* Massive alcoholic anamnesis\n* Massive smoker \\>20 cigarettes per day at present'}, 'identificationModule': {'nctId': 'NCT03932292', 'briefTitle': 'Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bitop AG'}, 'officialTitle': 'Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis', 'orgStudyIdInfo': {'id': 'btph-002-2018-EML03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ectoin Mouth Wash', 'description': '30 patients obtaining EML03 treatment', 'interventionNames': ['Drug: Ectoin Mouth Wash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supersaturated solution of calcium and phosphate ions', 'description': '20 patients taking standard treatment (calcium phosphate mouth wash)', 'interventionNames': ['Drug: Supersaturated solution of calcium and phosphate ions']}], 'interventions': [{'name': 'Ectoin Mouth Wash', 'type': 'DRUG', 'description': 'According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)', 'armGroupLabels': ['Ectoin Mouth Wash']}, {'name': 'Supersaturated solution of calcium and phosphate ions', 'type': 'DRUG', 'description': 'According to medical prescription of the instruction for use under consideration (4 times a day).', 'armGroupLabels': ['Supersaturated solution of calcium and phosphate ions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Department of Radiotherapy, National Institute of Oncology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Andreas Bilstein, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bitop AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitop AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}