Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study group
Herbal formula 5g daily, and Zometa
干预措施: 4 Herbs Formula (Drug)
Control group
Zometa alone
干预措施: 4 Herbs Formula (Drug)
结局指标
主要结局
reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
时间窗: 3 months
SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).
次要结局
- Survival rate and survival time(Proportion of participants in all groups with overall survival at 1 year)
研究者
Cheng King Fai
Principal Investigator
Chinese University of Hong Kong