Efficacy of a Herbal Formula for Bone Metastases

Chinese University of Hong Kong36 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Bone Metastases

Interventions

4 Herbs FormulaDRUG

4 herbs formula dose: 5g/day

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Secondary Outcomes

Survival rate and survival time

Proportion of participants in each group with overall survival at 6 months

Time frame: Proportion of participants in all groups with overall survival at 1 year

Data from ClinicalTrials.gov

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