Efficacy of a Herbal Formula for Bone Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries

Conditions
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Bone Metastases

Intervention / Treatment
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* Drug: 4 Herbs Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Herbal formula 5g daily, and Zometa | Drug: 4 Herbs Formula<br>* 4 herbs formula dose: 5g/day<br>* Other names: Zometa;|
| Active Comparator: Control group<br>Zometa alone | Drug: 4 Herbs Formula<br>* 4 herbs formula dose: 5g/day<br>* Other names: Zometa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing the morbidities of Skeletal-related events (SRES) extending survival time | 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 | Proportion of participants in each group with overall survival at 6 months | Proportion of participants in all groups with overall survival at 1 year |