Efficacy of a Herbal Formula for Bone Metastases

NCT06023420 — Phase 1 / Phase 2, Unknown, 36 participants, Chinese University of Hong Kong

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

Registry	NCT06023420
Status	Unknown
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	36 (Estimated)
Sponsor	Chinese University of Hong Kong (Other)
Conditions	Bone Metastases
Interventions	4 Herbs Formula (Drug)
Dates	start 2024-02-01 (estimated), primary completion 2024-12-31 (estimated), completion 2025-01-01 (estimated), first posted 2023-09-05, last updated 2023-09-07

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Study group	Experimental	Drug: 4 Herbs Formula	Herbal formula 5g daily, and Zometa
Control group	Active comparator	Drug: 4 Herbs Formula	Zometa alone

4 Herbs Formula (Drug), also known as Zometa: 4 herbs formula dose: 5g/day

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any

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