Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-19 @ 1:18 PM
Study NCT ID:
NCT03376035
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2017-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Assessing Breast Temperature in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Determine skin temperature after breast reconstruction'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in skin temperature after breast reconstruction', 'timeFrame': '6 months after surgery', 'description': 'Temperature measurements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.', 'detailedDescription': 'Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous sensation, degree of scar formation, nipple projection and overall appearance are well correlated with patient satisfaction. However, very little data exists on the importance of skin temperature after mastectomy and reconstruction. Our investigators have noted that a number of patients report their reconstructed breast is cold and relate this as a source of dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is cold and if so 2) can something can be done to improve this. Our investigators hypothesize that cutaneous breast temperature may be altered after mastectomy and reconstruction. This may be dependent on the reconstruction technique and other patient factors. In this pilot study, our investigators aim to establish techniques for evaluating cutaneous breast temperature following mastectomy and reconstruction. Our investigators hope to establish baseline data to develop an understanding of breast skin temperature after mastectomy and reconstruction.\n\nOur long-term goals are to evaluate how cutaneous breast temperature may contribute to patient satisfaction. Our investigators also hope to determine which patients are at risk for developing a cold breast after surgery. Finally, our investigators will setup a prospective trial evaluating techniques to correct this problem and improve patient satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at Duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction.\n\nExclusion Criteria:\n\n* Metastatic malignancy of any kind.\n* Subjects with a history of breast implant augmentation prior to mastectomy and reconstruction.\n* Subjects who cannot give an informed consent.'}, 'identificationModule': {'nctId': 'NCT03376035', 'briefTitle': 'Pilot Study Assessing Breast Temperature in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pilot Study Assessing Cutaneous Breast Temperature in the Setting of Mastectomy and Reconstruction', 'orgStudyIdInfo': {'id': 'Pro00084743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral breast reconstruction', 'description': 'Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.', 'interventionNames': ['Other: Temperature measurement of breast']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral breast reconstruction', 'description': 'Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.', 'interventionNames': ['Other: Temperature measurement of breast']}], 'interventions': [{'name': 'Temperature measurement of breast', 'type': 'OTHER', 'description': 'Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.', 'armGroupLabels': ['Bilateral breast reconstruction', 'Unilateral breast reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Scott Hollenbeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}