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NCT06023420 Clinical Trial

Efficacy of a Herbal Formula for Bone Metastases

Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06023420
Other study ID # 2021.746-T
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 1, 2024
Est. completion date January 1, 2025

Study information
Verified date September 2023
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date January 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 4 Herbs Formula
4 herbs formula dose: 5g/day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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