Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-04 @ 1:43 PM
Study NCT ID:
NCT04650256
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000529', 'term': 'Complementary Therapies'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients free of clinically relevant skin toxicities', 'timeFrame': 'Up to 18 weeks.', 'description': 'Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.'}], 'secondaryOutcomes': [{'measure': 'SD-16 scores', 'timeFrame': 'Up to 18 weeks.', 'description': "Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects."}, {'measure': 'Functional Assessment of Cancer Therapy-Breast (FACT-B) scores', 'timeFrame': 'Up to 18 weeks.', 'description': "FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life."}, {'measure': 'High-sensitivity C-reactive protein (hsCRP) values', 'timeFrame': 'Up to 6 weeks', 'description': 'The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Radiotherapy', 'Complementary and alternative medicine'], 'conditions': ['Skin Toxicity']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects with newly diagnosed breast carcinoma\n* \\> 18 years of age\n* Post-mastectomy with or without reconstruction\n* Stage II-IIIb with any receptor status\n* All races and ethnicities are eligible\n* Patients must be able to consent in English or Spanish\n* Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes\n* RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)\n* Willing to sign protocol consent form\n* Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.\n* Patients may receive chemotherapy before or after radiation therapy\n\nExclusion Criteria:\n\n* Prior radiation to the involved breast or chest wall\n* Concurrent chemotherapy\n* Unable or unwilling to sign informed consent\n* Unable to speak English or Spanish\n* Pregnant women\n* Clinical or pathologic stage T4\n* Metastatic disease\n* Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma'}, 'identificationModule': {'nctId': 'NCT04650256', 'briefTitle': 'Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences', 'orgStudyIdInfo': {'id': '20200491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAM arm', 'description': 'Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.', 'interventionNames': ['Other: Complementary and alternative medicine (CAM)']}], 'interventions': [{'name': 'Complementary and alternative medicine (CAM)', 'type': 'OTHER', 'description': 'CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.', 'armGroupLabels': ['CAM arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer J Hu, PhD', 'role': 'CONTACT', 'email': 'jhu@med.miami.edu', 'phone': '305-243-7796'}, {'name': 'Jennifer J Hu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Jennifer J Hu, PhD', 'role': 'CONTACT', 'email': 'jhu@med.miami.edu', 'phone': '3052437796'}], 'overallOfficials': [{'name': 'Jennifer J Hu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U. of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'VAUGHN-JORDAN FOUNDATION, INC.', 'class': 'UNKNOWN'}, {'name': 'Florida Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jennifer Hu', 'investigatorAffiliation': 'University of Miami'}}}}