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
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis

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