Efficacy of a Herbal Formula for Bone Metastases

Phase 1

Not yet recruiting

• Conditions: Bone Metastases
• Interventions: Drug: 4 Herbs Formula

• Registration Number: NCT06023420
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2023-08-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-07
• Study Start: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	4 Herbs Formula	Zometa alone
Study group	4 Herbs Formula	Herbal formula 5g daily, and Zometa

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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