Efficacy of a Herbal Formula for Bone Metastases

September 4, 2023 updated by: Cheng King Fai, Chinese University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Herbal formula 5g daily, and Zometa
Drug: 4 Herbs Formula
4 herbs formula dose: 5g/day
Other Names:
  • Zometa
Active Comparator: Control group
Zometa alone
Drug: 4 Herbs Formula
4 herbs formula dose: 5g/day
Other Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reducing the morbidities of "Skeletal-related events" (SRES) extending survival time
Time Frame: 3 months
SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate and survival time
Time Frame: Proportion of participants in all groups with overall survival at 1 year
Proportion of participants in each group with overall survival at 6 months
Proportion of participants in all groups with overall survival at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.746-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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