Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00702858
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018771', 'term': 'Arthralgia'}], '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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo', 'timeFrame': '6 months'}, {'measure': 'Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Joint Pain', 'Aromatase Inhibitors'], 'conditions': ['Breast Cancer', 'Joint Pain']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).\n\nAnother purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.', 'detailedDescription': 'Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level \\>40\n2. Patient complaints of musculoskeletal symptoms\n3. Currently taking AIT for ER positive postmenopausal breast cancer\n\nExclusion Criteria:\n\n1. Previously taken Blue Citrus\n2. Presence of bone metastasis\n3. Unable to complete VAS Pain Scale\n4. Unable to comply/complete SF 12 Quality of Life survey\n5. Plan to discontinue AIT in less then six months\n6. Unable to complete ADL scale\n7. Have diagnosis of fibromyalgia\n8. Have diagnosis of rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT00702858', 'briefTitle': 'Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Legacy Health System'}, 'officialTitle': 'Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy', 'orgStudyIdInfo': {'id': 'Blue Citrus BC-AIT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Blue Citrus either months 1-3 or 4-6', 'interventionNames': ['Drug: Blue Citrus']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Blue Citrus', 'type': 'DRUG', 'description': 'Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Five Placebo capsules three times a day to equal 15 capsules per day for 3 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nathalie Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Legacy Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Legacy Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nathalie Johnson', 'investigatorAffiliation': 'Legacy Health System'}}}}