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Efficacy of a Herbal Formula for Bone Metastases

Primary Purpose

Bone Metastases

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
4 Herbs Formula
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study group

    Control group

    Arm Description

    Herbal formula 5g daily, and Zometa

    Zometa alone

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Survival rate and survival time
    Proportion of participants in each group with overall survival at 6 months

    Full Information

    First Posted
    June 13, 2022
    Last Updated
    September 4, 2023
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06023420
    Brief Title
    Efficacy of a Herbal Formula for Bone Metastases
    Official Title
    Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Metastases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Herbal formula 5g daily, and Zometa
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Zometa alone
    Intervention Type
    Drug
    Intervention Name(s)
    4 Herbs Formula
    Other Intervention Name(s)
    Zometa
    Intervention Description
    4 herbs formula dose: 5g/day
    Primary Outcome Measure Information:
    Title
    reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
    Description
    SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Survival rate and survival time
    Description
    Proportion of participants in each group with overall survival at 6 months
    Time Frame
    Proportion of participants in all groups with overall survival at 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of a Herbal Formula for Bone Metastases

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