Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT02606994
Status:
TERMINATED
Last Update Posted:
2019-02-06
First Post:
2015-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052016', 'term': 'Mucositis'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546060', 'term': 'hydrated silica gel-based toothpaste'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C013591', 'term': 'aluminum hydroxide, magnesium hydroxide, drug combination'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2015-11-01', 'studyFirstSubmitQcDate': '2015-11-15', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral mucositis changes', 'timeFrame': 'Day 1 and 8 of the study', 'description': 'The primary measure is the healing of chemotherapy induced oral mucositis lesions which are evaluated at days 1 and 8 of the study. The clinical investigators will identify patients who qualify for the study and this will mark day 1 of the study. At days 1 and 8 of the study, the clinical investigators will evaluate the oral cavity of each study participant and document changes in the oral mucositis of the participants.'}], 'secondaryOutcomes': [{'measure': 'Quality of life changes', 'timeFrame': '8 days', 'description': 'Each participant will fill out a quality of life questionnaire every day of the study. An evaluated outcome is when their chemotherapy induced oral mucositis lesions have resolved and their quality of life has returned to pre-chemotherapy levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral mucositis', 'chemotherapy', 'toothpaste'], 'conditions': ['Mucositis', 'Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.', 'detailedDescription': 'A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste.\n\nIn this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 receiving chemotherapy\n* Mucositis lesions not exceeding grade 2\n\nExclusion Criteria:\n\n* Patients receiving high load chemotherapy\n* Patients receiving radiation therapy\n* Patients receiving oral antivirals, oral antifungals or oral antibacterials\n* Patients experiencing oral candidiasis'}, 'identificationModule': {'nctId': 'NCT02606994', 'acronym': 'TPvsM', 'briefTitle': 'Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oral Defense, LLC'}, 'officialTitle': 'Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse', 'orgStudyIdInfo': {'id': 'OralDefenseMucositisStudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Defense Toothpaste', 'description': 'The experimental group will brush with Oral Defense Toothpaste three times per day during the study', 'interventionNames': ['Drug: Oral Defense Toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Crest Toothpaste/Magic Mouth Rinse', 'description': 'The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse.', 'interventionNames': ['Drug: Crest Toothpaste', 'Drug: Magic Mouth Rinse']}], 'interventions': [{'name': 'Oral Defense Toothpaste', 'type': 'DRUG', 'otherNames': ['Experimental toothpaste'], 'description': 'Brush with a Oral Defense Toothpaste three times per day during the study', 'armGroupLabels': ['Oral Defense Toothpaste']}, {'name': 'Crest Toothpaste', 'type': 'DRUG', 'otherNames': ['Control Toothpaste'], 'description': 'Brush with Crest Toothpaste three times per day during the study', 'armGroupLabels': ['Crest Toothpaste/Magic Mouth Rinse']}, {'name': 'Magic Mouth Rinse', 'type': 'DRUG', 'otherNames': ['Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml'], 'description': 'Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse', 'armGroupLabels': ['Crest Toothpaste/Magic Mouth Rinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Summit Cancer Centers', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Arvind Chaudhry, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summit Cancer Centers, Seattle Cancer Care Alliance'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oral Defense, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}