Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-06-16 @ 5:22 PM
Study NCT ID:
NCT02935569
Status:
TERMINATED
Last Update Posted:
2017-02-28
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Results with 4 subjects suggest a redesign of Compression system is required.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3', 'timeFrame': 'baseline to 6 weeks', 'description': 'The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.\n\nThe amount of hair loss will be evaluated at the following time points.\n\n* Before whole brain radiation\n* six weeks following radiation'}], 'secondaryOutcomes': [{'measure': 'Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation', 'timeFrame': '6 weeks', 'description': 'Does a temporary compression headband cause side effects in patients undergoing whole brain ? Nausea? Headache? Redness? Tingling?'}, {'measure': 'Timing of hair regrowth', 'timeFrame': 'one year', 'description': 'If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?'}, {'measure': 'Acute hypoxia in the scalp of normal volunteers caused by compression headband (if present, to what degree?) as measured by a transcutaneous oxygen pressure monitor', 'timeFrame': '1 hour', 'description': 'In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alopecia', 'Radiotherapy'], 'conditions': ['Alopecia']}, 'descriptionModule': {'briefSummary': 'This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation.', 'detailedDescription': 'This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question:\n\n1. Does a compression headband, placed only at the time of irradiation, reduce the incidence of significant hair loss after whole brain radiation, as compared to historical controls?\n\n This study will also seek to answer these secondary questions:\n2. Is a temporary compression headband well tolerated in patients undergoing whole brain radiation?\n3. If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?\n4. In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years old.\n* Undergoing whole brain radiation therapy, using lateral opposed fields\n* Total planned radiation prescription dose between 30 Gy and 37.5 Gy in 10 to 15 treatments.\n\nExclusion Criteria:\n\n* Current complete or near-complete alopecia (natural or chemotherapy-induced)\n* Concurrent or sequential chemotherapy with an agent known to commonly cause alopecia (Adriamycin, Cytoxan, Ifosfamide, Taxol (greater than 50 mg/m2), or Vincristine).\n* Previous Radiation to the Scalp\n* Any active dermatologic disease affecting the scalp, or temporal arteritis\n* History of severe headaches.'}, 'identificationModule': {'nctId': 'NCT02935569', 'briefTitle': 'Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy', 'orgStudyIdInfo': {'id': 'UCCP12009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compression Headband', 'description': 'a compression headband, placed only at the time of irradiation', 'interventionNames': ['Device: Compression HeadBand']}], 'interventions': [{'name': 'Compression HeadBand', 'type': 'DEVICE', 'description': '* commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1" x 18" x .025") with Velcro adhesion\n* Plastics disks, hollow (3.5 cm diameter, by 1 cm height)\n\nTwo bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery.', 'armGroupLabels': ['Compression Headband']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Dept. of Radiation Oncology, University of Rochester, Med Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Michael Milano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Researchers can contact the PI to obtain IPD with collaboration.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Milano, MD,PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc Professor, Radiation Oncology', 'investigatorFullName': 'Michael Milano, MD,PhD', 'investigatorAffiliation': 'University of Rochester'}}}}