Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT02369835
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012973', 'term': 'Sodium Hypochlorite'}], 'ancestors': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bbeadle@stanford.edu', 'phone': '650-723-6194', 'title': 'Beth Beadle', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study - from consent to the end of follow-up (follow-up visit 3 to 12 weeks after completion of treatment). Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.', 'description': 'Reported adverse events represent the entire set of adverse events as available to the current investigator and Responsible Party. There are no additional events available to report, and there never will be.', 'eventGroups': [{'id': 'EG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.", 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 53, 'seriousNumAtRisk': 64, 'deathsNumAffected': 1, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 55, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Radiation dermatitis', 'notes': 'Development of grade 1 or higher non-serious radiation dermatitis (per CTCAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 55, 'numAffected': 55}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}], 'seriousEvents': [{'term': 'Radiation dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Acneiform Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Other, Foot ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Other, shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Aspiration, pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Colonic perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Other, Feeding tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}, {'term': 'Pain, shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.03'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment."}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.8872', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.', 'description': 'Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion.\n\nSRDSS, by grade:\n\n* A. No skin change\n* B. Faint, barely detectable erythema\n* C. Follicular rash, hyperpigmentation, evolving erythema\n* D. Dry desquamation, brisk erythema\n* E. Moist desquamation\n* F. Bleeding, ulceration, and/or infection\n\nSRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed radiation treatment, and are not included in the outcome.'}, {'type': 'SECONDARY', 'title': 'Time to Grade E Radiation Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment."}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.'}], 'timeFrame': 'up to 12 weeks (estimated)', 'description': 'Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation.\n\nSRDSS, by grade:\n\n* A. No skin change\n* B. Faint, barely detectable erythema\n* C. Follicular rash, hyperpigmentation, evolving erythema\n* D. Dry desquamation, brisk erythema\n* E. Moist desquamation\n* F. Bleeding, ulceration, and/or infection\n\nSRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."\n\nAdditional information describing this outcome is not available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for time to Grade E radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.'}, {'type': 'SECONDARY', 'title': 'Pain Associated With Radiation Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment."}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.'}], 'timeFrame': '3 to 12 weeks after completion of radiation treatment', 'description': 'Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation.\n\nAdditional information describing this outcome is not available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for pain associated with radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment."}, {'id': 'FG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Reasons that participants did not complete for the Primary Outcome are not available.', 'groupId': 'FG000', 'numSubjects': '53'}, {'comment': 'Reasons that participants did not complete for the Primary Outcome are not available.', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Arm I (Modified Dakin's Solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment."}, {'id': 'BG001', 'title': 'Arm II (Placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '62', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline dermatitis', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-13', 'size': 714528, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-14T14:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2015-02-17', 'resultsFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2015-02-17', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-09', 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Dermatitis', 'timeFrame': 'From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.', 'description': 'Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion.\n\nSRDSS, by grade:\n\n* A. No skin change\n* B. Faint, barely detectable erythema\n* C. Follicular rash, hyperpigmentation, evolving erythema\n* D. Dry desquamation, brisk erythema\n* E. Moist desquamation\n* F. Bleeding, ulceration, and/or infection\n\nSRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"'}], 'secondaryOutcomes': [{'measure': 'Time to Grade E Radiation Dermatitis', 'timeFrame': 'up to 12 weeks (estimated)', 'description': 'Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation.\n\nSRDSS, by grade:\n\n* A. No skin change\n* B. Faint, barely detectable erythema\n* C. Follicular rash, hyperpigmentation, evolving erythema\n* D. Dry desquamation, brisk erythema\n* E. Moist desquamation\n* F. Bleeding, ulceration, and/or infection\n\nSRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."\n\nAdditional information describing this outcome is not available.'}, {'measure': 'Pain Associated With Radiation Dermatitis', 'timeFrame': '3 to 12 weeks after completion of radiation treatment', 'description': 'Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation.\n\nAdditional information describing this outcome is not available.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Carcinoma', 'Radiation-Induced Dermatitis']}, 'descriptionModule': {'briefSummary': "This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.\n\nRadiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the Stanford Radiation Dermatitis Scoring System) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (HOCl) (modified Dakin\'s solution) at the start of therapy (experimental arm) compared to placebo (control arm).\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I (EXPERIMENTAL): Participants apply modified Dakin\'s solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.\n\nARM II (CONTROL): Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.\n\nAt the time that Stanford Radiation Dermatitis Scoring System (SRDSS) Grade E radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. SRDSS, by grade, is as follows.\n\n* A. No skin change\n* B. Faint, barely detectable erythema\n* C. Follicular rash, hyperpigmentation, evolving erythema\n* D. Dry desquamation, brisk erythema\n* E. Moist desquamation\n* F. Bleeding, ulceration, and/or infection\n\nSRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."\n\nAfter completion of study, patients are followed up at 6 to 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and neck cancer who plan to undergo radiation therapy to the head and neck region\n* At least 18 years of age\n* Able to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)\n* The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy\n* Scleroderma or discoid lupus'}, 'identificationModule': {'nctId': 'NCT02369835', 'briefTitle': "Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy", 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': "A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer", 'orgStudyIdInfo': {'id': 'IRB-32439'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00176', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'IRB-32439', 'type': 'OTHER', 'domain': 'Stanford IRB'}, {'id': 'ENT0042', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Arm I (modified Dakin's solution)", 'description': "Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.", 'interventionNames': ["Drug: Dakin's solution"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': "Dakin's solution", 'type': 'DRUG', 'otherNames': ['Sodium hypochlorite in aqueous solution', "Dakin's fluid", 'Liquid bleach'], 'description': "Apply modified Dakin's solution (0.005 to 0.01%) topically", 'armGroupLabels': ["Arm I (modified Dakin's solution)"]}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Applied topically', 'armGroupLabels': ['Arm II (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center South Bay', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Beth Beadle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University Hospitals and Clinics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiation Oncology', 'investigatorFullName': 'Beth Beadle', 'investigatorAffiliation': 'Stanford University'}}}}