- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023420
Efficacy of a Herbal Formula for Bone Metastases
Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
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.
PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of "Skeletal-related events" (SRES), and survival time.
Study Overview
Detailed Description
OBJECTIVES:
Primary 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)
OUTLINE:
Patients 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older
- Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone
- Confirmed diagnosis of metastatic breast cancer
- Radiographic proof of metastatic bone disease
- Informed consent obtained
Exclusion Criteria:
- Known history of primary bone tumors (benign and/or malignant)
- Prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry
- 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].
- Significant drug hypersensitivity
- No informed consent signed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Herbal formula 5g daily, and Zometa
|
4 herbs formula dose: 5g/day
Other Names:
|
Active Comparator: Control group
Zometa alone
|
4 herbs formula dose: 5g/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
Time Frame: 3 months
|
SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate and survival time
Time Frame: Proportion of participants in all groups with overall survival at 1 year
|
Proportion of participants in each group with overall survival at 6 months
|
Proportion of participants in all groups with overall survival at 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.746-T
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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