Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT03883828
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2019-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bacterial Decolonization to Prevent Radiation Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmclella@montefiore.org', 'phone': '718.862.8840', 'title': 'Dr. Beth McLellan', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse event monitoring period spanned the duration of the intervention (5 days before radiotherapy start and until the last day of radiotherapy) for each patient. This varies per patient between 5 to 8 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 1, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Incidence of High Grade Radiation Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Multivariable Linear Regression', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.15', 'pValueComment': 'Two-sided p-values equal to or less than 0.05 were considered statistically significant', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks", 'description': 'The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'PRIMARY', 'title': 'Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.'}], 'classes': [{'title': 'Symptoms', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Emotions', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '6'}]}]}, {'title': 'Functioning', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A 2-sided P ≤ .05 was considered statistically significant', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Symptoms Domain'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A 2-sided P ≤ .05 was considered statistically significant', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Emotions Domain'}, {'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A 2-sided P ≤ .05 was considered statistically significant', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Functioning Domain'}], 'paramType': 'MEDIAN', 'timeFrame': "From the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks", 'description': "Change in quality of life from the beginning to the end of radiation therapy was used to assess if patients receiving decolonization experienced less impact on quality of life compared to standard of care radiation therapy treatment based on the Skindex-16 survey. The Skindex-16 is a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores were determined based on changes from baseline in the three scale subcategories: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30) where 0 = never bothered and 6 = always bothered. Net positive changes in respective subscale scoring were correlated with an improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring corresponded to a decrease in that particular Quality of life assessment.", 'unitOfMeasure': 'change in score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. Data was not collected from one participant in the treatment arm and one participant in the control arm resulting in 38 and 37 participants analyzed in the treatment and control arms, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Did not start radiotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Enrollment took place at Montefiore Medical Center between June 2019 and August 2021. The first participant was enrolled into the study on June 3, 2019', 'preAssignmentDetails': '80 patients were randomly assigned in a 1:1 manner to either the bacterial decolonization (treatment) arm or standard of care (control) arm. Three patients (1 assigned to the bacterial decolonization arm and 2 assigned to the control arm) were excluded from analysis because they did not start radiation therapy after enrollment. As such, the final population included 77 patients with breast cancer or head and neck cancer (39 assigned in the treatment arm and and 38 in the standard of care arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.\n\nChlorhexidine gluconate solution: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.\n\nMupirocin Ointment: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.36', 'spread': '10.54', 'groupId': 'BG000'}, {'value': '60.42', 'spread': '13.26', 'groupId': 'BG001'}, {'value': '59.88', 'spread': '11.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.55', 'spread': '6.07', 'groupId': 'BG000'}, {'value': '30.10', 'spread': '5.20', 'groupId': 'BG001'}, {'value': '29.45', 'spread': '5.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cancer Type', 'classes': [{'categories': [{'title': 'Breast', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Head and Neck', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Radiation Dose', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'groupId': 'BG000', 'lowerLimit': '42.4', 'upperLimit': '52.4'}, {'value': '52.4', 'groupId': 'BG001', 'lowerLimit': '42.4', 'upperLimit': '52.4'}, {'value': '52.4', 'groupId': 'BG002', 'lowerLimit': '42.4', 'upperLimit': '52.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Gy', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total Number of Fractions Delivered', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '20', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'fractions', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Concurrent Chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Nasal Staph. aureus Colonization', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Silver Sulfadiazine Use', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline information and data was only collected for 77 participants (39 in the treatment arm and 38 in the control arm)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-13', 'size': 8751954, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-05T08:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2019-02-18', 'resultsFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-08', 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Incidence of High Grade Radiation Dermatitis', 'timeFrame': "Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks", 'description': 'The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.'}, {'measure': 'Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey', 'timeFrame': "From the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks", 'description': "Change in quality of life from the beginning to the end of radiation therapy was used to assess if patients receiving decolonization experienced less impact on quality of life compared to standard of care radiation therapy treatment based on the Skindex-16 survey. The Skindex-16 is a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores were determined based on changes from baseline in the three scale subcategories: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30) where 0 = never bothered and 6 = always bothered. Net positive changes in respective subscale scoring were correlated with an improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring corresponded to a decrease in that particular Quality of life assessment."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Dermatitis']}, 'referencesModule': {'references': [{'pmid': '37140904', 'type': 'DERIVED', 'citation': 'Kost Y, Deutsch A, Mieczkowska K, Nazarian R, Muskat A, Hosgood HD, Lin J, Daily JP, Ohri N, Kabarriti R, Shinoda K, McLellan BN. Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):940-945. doi: 10.1001/jamaoncol.2023.0444.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent\n\nExclusion Criteria:\n\n* Prior RT to the region of interest\n* Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds)\n* Known allergy to chlorhexidine or mupirocin'}, 'identificationModule': {'nctId': 'NCT03883828', 'briefTitle': 'Bacterial Decolonization to Prevent Radiation Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment', 'orgStudyIdInfo': {'id': '2018-9722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.', 'interventionNames': ['Drug: Chlorhexidine gluconate solution', 'Drug: Mupirocin Ointment']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.'}], 'interventions': [{'name': 'Chlorhexidine gluconate solution', 'type': 'DRUG', 'description': 'Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Mupirocin Ointment', 'type': 'DRUG', 'description': 'Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Beth McLellan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}