Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 9:26 PM
Study NCT ID:
NCT06023420
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Herbal Formula for Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reducing the morbidities of "Skeletal-related events" (SRES) extending survival time', 'timeFrame': '3 months', 'description': 'SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).'}], 'secondaryOutcomes': [{'measure': 'Survival rate and survival time', 'timeFrame': 'Proportion of participants in all groups with overall survival at 1 year', 'description': 'Proportion of participants in each group with overall survival at 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Metastases']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications collectively termed skeletal-related events (SREs). The study herbal medicine might reduce the morbidities due to "Skeletal-related events" (SRES), and extend survival time.\n\nPURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of "Skeletal-related events" (SRES), and survival time.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of Life: EQ5-D Pain control (Brief Pain Inventory)\n\nOUTLINE:\n\nPatients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone\n* Confirmed diagnosis of metastatic breast cancer\n* Radiographic proof of metastatic bone disease\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Known history of primary bone tumors (benign and/or malignant)\n* Prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry\n* Active anti-cancer therapies in the form of cytotoxics or targeted therapies. \\[Patients who are currently on hormonal therapies, including but not limited to tamoxifen, aromatase inhibitors and LHRH agonists/antagonists are allowed for study entry. Clarifications shall be sought from investigators if in doubt\\].\n* Significant drug hypersensitivity\n* No informed consent signed'}, 'identificationModule': {'nctId': 'NCT06023420', 'briefTitle': 'Efficacy of a Herbal Formula for Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries', 'orgStudyIdInfo': {'id': '2021.746-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Herbal formula 5g daily, and Zometa', 'interventionNames': ['Drug: 4 Herbs Formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Zometa alone', 'interventionNames': ['Drug: 4 Herbs Formula']}], 'interventions': [{'name': '4 Herbs Formula', 'type': 'DRUG', 'otherNames': ['Zometa'], 'description': '4 herbs formula dose: 5g/day', 'armGroupLabels': ['Control group', 'Study group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cheng King Fai', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}