Efficacy of a Herbal Formula for Bone Metastases
Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 7, 2023
September 1, 2023
11 months
June 13, 2022
September 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Survival rate and survival time
Proportion of participants in all groups with overall survival at 1 year
Study Arms (2)
Study group
EXPERIMENTALHerbal formula 5g daily, and Zometa
Control group
ACTIVE COMPARATORZometa alone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 13, 2022
First Posted
September 5, 2023
Study Start
February 1, 2024
Primary Completion
December 31, 2024
Study Completion
January 1, 2025
Last Updated
September 7, 2023
Record last verified: 2023-09