Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-03-15 @ 1:43 AM
Study NCT ID:
NCT01941992
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C580632', 'term': 'samital'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2013-09-10', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life assessed by European Organization for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) and specific head and neck module (QLQ-H&N35)', 'timeFrame': 'Within 19 weeks after starting Radiotherapy'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.', 'timeFrame': 'Within 19 weeks after starting Radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)', 'timeFrame': 'Within 19 weeks after starting Radiotherapy'}]}, 'conditionsModule': {'keywords': ['head and neck', 'Squamous Cell Carcinoma', 'oral mucositis', 'Chemo-radiotherapy'], 'conditions': ['Head-and-neck Squamous Cell Carcinoma', 'Oral Mucositis']}, 'referencesModule': {'references': [{'pmid': '36551677', 'type': 'DERIVED', 'citation': 'Fasanaro E, Del Bianco P, Groff E, Riva A, Petrangolini G, Busato F, Stritoni P, Scarzello G, Loreggian L, De Salvo GL. Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM). Cancers (Basel). 2022 Dec 15;14(24):6192. doi: 10.3390/cancers14246192.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n* evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.\n* assess tolerability of SAMITAL and the impact on patients reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven squamous cell carcinomas of the head-and-neck\n* Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx\n* Stage III or IV disease without evidence of distant metastases\n* Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy\n* Age ≥ 18 years\n* Karnofsky Performance Status ≥70\n* Life expectancy ≥6 months\n* Able to swallow and retain oral medication\n* Good state of dentition\n* Patients must be available for treatment and follow-up\n* Confirmation of adequate contraception use by the patient and/or partner\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx\n* Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.\n* Chronic administration of steroids or immunosuppressants\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT01941992', 'acronym': 'ROSAM', 'briefTitle': 'Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Oncologico Veneto IRCCS'}, 'officialTitle': 'Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.', 'orgStudyIdInfo': {'id': 'IOV-HN-1-2012 ROSAM'}, 'secondaryIdInfos': [{'id': '2012-002046-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAMITAL® sachets, oral suspension', 'description': 'SAMITAL® sachets for oral suspension, 20 mL, four times a day.', 'interventionNames': ['Drug: SAMITAL®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo sachets', 'description': 'Placebo sachets for oral suspension, 20 mL, four times a day.', 'interventionNames': ['Drug: Placebo sachets']}], 'interventions': [{'name': 'SAMITAL®', 'type': 'DRUG', 'armGroupLabels': ['SAMITAL® sachets, oral suspension']}, {'name': 'Placebo sachets', 'type': 'DRUG', 'armGroupLabels': ['Placebo sachets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Padua', 'country': 'Italy', 'facility': 'Radiotherapy Department, Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Lucio Loreggian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiotherapy Department, Istituto Oncologico Veneto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Oncologico Veneto IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indena S.p.A', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}