NCT06023420

Efficacy of a Herbal Formula for Bone Metastases

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
DRUG	4 Herbs Formula	4 herbs formula dose: 5g/day

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-31
• Completion: 2025-01-01
• First posted: 2023-09-05
• Last updated: 2023-09-07