Bone MetastasesPhase 1/2NCT06023420
Efficacy of a Herbal Formula for Bone Metastases
A Phase 1/2 study testing 4 Herbs Formula in people with Bone Metastases, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bone Metastases
- What is being tested?
- 4 Herbs Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- 4 Herbs Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 Herbs FormulaDrug
Also called Zometa
4 herbs formula dose: 5g/day
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Herbal formula 5g daily, and Zometa Receives: Drug: 4 Herbs Formula |
| Control group | Active comparator | Zometa alone Receives: Drug: 4 Herbs Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
Survival rate and survival time
Proportion of participants in each group with overall survival at 6 months
Measured: Proportion of participants in all groups with overall survival at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng King Fai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023420
- Sponsor's protocol ID
- 2021.746-T
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
- ClinicalTrials.gov ID
- NCT06023420
- Acronym / sponsor ID
- 2021.746-T
- Conditions
- Bone Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: 4 Herbs FormulaHerbal formula 5g daily, and Zometa |
| Control group | Active comparator | Drug: 4 Herbs FormulaZometa alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 Herbs FormulaAlso: Zometa4 herbs formula dose: 5g/day | Drug | Control group, Study group |
Primary outcome
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).
1 secondary outcome
Survival rate and survival time
Time frame: Proportion of participants in all groups with overall survival at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 4 Herbs Formula in people with Bone Metastases, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reducing the morbidities of "Skeletal-related events" (SRES) extending survival time (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.