Bone Metastases
Conditions
Brief summary
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
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.
Interventions
DRUG4 Herbs Formula
4 herbs formula dose: 5g/day
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reducing the morbidities of Skeletal-related events (SRES) extending survival time | 3 months | SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate and survival time | Proportion of participants in all groups with overall survival at 1 year | Proportion of participants in each group with overall survival at 6 months |
Outcome results
None listed