Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00060320
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D019584', 'term': 'Hot Flashes'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713173', 'term': 'black cohosh root extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2003-05-06', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot flash activity', 'timeFrame': 'Up to 3.5 years'}], 'secondaryOutcomes': [{'measure': 'Reduction of hot flash score', 'timeFrame': 'Up to 3.5 years'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 3.5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'hot flashes'], 'conditions': ['Breast Cancer', 'Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '16782922', 'type': 'RESULT', 'citation': 'Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, Lavasseur BI, Rao RM, Fitch TR, Rowland KM, Novotny PJ, Flynn PJ, Richelson E, Fauq AH. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol. 2006 Jun 20;24(18):2836-41. doi: 10.1200/JCO.2005.05.4296.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in women.\n\nPURPOSE: Randomized phase III trial to determine the effectiveness of black cohosh in relieving hot flashes in women who have breast cancer or who are at risk of developing breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of black cohosh vs placebo in diminishing hot flash activity in women with breast cancer OR a concern about taking hormones because of a fear of breast cancer.\n* Determine whether continued use of this drug by these patients leads to prolonged reduction of the hot flash score with minimal toxic effects.\n* Correlate the reduction of hot flash score with improvement in quality of life and related outcomes in patients treated with this drug.\n* Determine the toxic effects of this drug in these patients.\n* Determine whether abnormal sweating is decreased in patients treated with this drug.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no vs unknown), current raloxifene use (yes vs no vs unknown), current aromatase inhibitor use (yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral black cohosh twice daily for 4 weeks.\n* Arm II: Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment as above for 4 weeks.\n\nAfter completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks.\n\nPatients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment.\n\nPatients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.\n\nPROJECTED ACCRUAL: A total of 110 patients (55 patients per arm) will be accrued for this study within 6-11 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* History of breast cancer OR concern about taking hormones because of fear of breast cancer\n\n * No current active disease\n * No current evidence of malignant disease\n* Bothersome hot flashes\n\n * Patient-reported occurrence at least 14 times per week and of sufficient severity to make the patient desire therapeutic intervention\n* Hormone receptor status:\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* At least 6 months\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to complete questionnaires alone or with assistance\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* More than 4 weeks since prior antineoplastic chemotherapy\n* No concurrent antineoplastic chemotherapy during the double-blind portion of the study\n\nEndocrine therapy\n\n* More than 4 weeks since prior androgens, estrogens, or progestational agents\n* More than 2 weeks since prior dehydroepiandrosterone (DHEA) for hot flashes\n* No concurrent androgens, estrogens, or progestational agents during the double-blind portion of the study\n* No concurrent DHEA for hot flashes\n* Concurrent tamoxifen, raloxifene, or an aromatase inhibitor is allowed provided the patient started the drug at least 4 weeks prior to study entry and plans to continue the drug throughout the double-blind portion of the study Other\n* More than 2 weeks since prior antidepressants\n* More than 2 weeks since other prior agents for treating hot flashes (e.g., clonidine or Bellergal-s)\n* No prior black cohosh\n* No concurrent antidepressants during the double-blind portion of the study\n* No other concurrent agents for treating hot flashes (e.g., clonidine or Bellergal-s)\n\n * Concurrent vitamin E and/or soy allowed provided patient is on a stable dose for at least 1 month prior to study entry and plans to continue the same dose throughout study duration\n* No concurrent oral herbal therapies or therapeutic herbal teas or tinctures except beverage teas (e.g., chamomile, ginger, peppermint, lemongrass, and fruit-based tea)'}, 'identificationModule': {'nctId': 'NCT00060320', 'briefTitle': 'Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes', 'orgStudyIdInfo': {'id': 'NCCTG-N01CC'}, 'secondaryIdInfos': [{'id': 'CDR0000301615', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'black cohost', 'description': 'Patients receive oral black cohosh twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment for 4 weeks.\n\nAfter completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks.\n\nPatients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment.\n\nPatients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.', 'interventionNames': ['Dietary Supplement: black cohosh', 'Other: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment for 4 weeks.\n\nAfter completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks.\n\nPatients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment.\n\nPatients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.', 'interventionNames': ['Dietary Supplement: black cohosh', 'Other: placebo']}], 'interventions': [{'name': 'black cohosh', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['black cohost', 'placebo']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['black cohost', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5404', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Mayo Clinic Scottsdale Oncology Program', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '50309-1016', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Iowa Oncology Research Association', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '51101-1733', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Michigan Cancer Research Consortium', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '68106', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CCOP - Missouri Valley Cancer Consortium', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '58501-5505', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Medcenter One Health System', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'CCOP - Merit Care Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'CCOP - Sioux Community Cancer Consortium', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Barbara A. Pockaj, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}