Metastatic Breast CancerPhase 2NCT06151249
Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy
A Phase 2 study testing Meritup oral solution in people with Metastatic Breast Cancer, run by Chung Shan Medical University.
Trial summary
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Meritup oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Nov 2025
- Phase
- Phase 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over 20years old and under 80 years old.
- Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.
- After at least 3 cycles of chemotherapy.
- Sign the subject Informed Consent Form (ICF).
Who cannot join
- Have received other clinical studies within 3 weeks
- Any uncontrollable infection
- History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis
- History of cancer cells that have metastasized to the brain
- Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs
- Currently using anti-fatigue treatments, including psychostimulants, acupuncture, etc. Note: Antidepressants are used for treatment to relieve fatigue (such as depression or hot flashes) is allowed,
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- Need to use long-acting sustained-release pain narcotic analgesics
- Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product
- Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate
- Lactation, pregnancy or planning pregnancy
- People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety and Ability of Meritup Oral Liquid to Reduce Fatigue in Patients With Metastatic Breast Cancer Receiving Chemotherapy
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.
Read the detailed description
The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive metastatic disease and at least completed 3 cycle chemotherapy regimen who have evidence of fatigue.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Meritup oral solution
- Keywords
- Metastatic Breast Cancer, Fatigue
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meritup oral solutionCombination product
chemotherapy + Meritup
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+Meritup | Experimental | Chemotherapy+Meritup 20ml TID Receives: Combination Product: Meritup oral solution |
| Chemotherapy+Placebo | Placebo comparator | Chemotherapy+Placebo 20ml TID Receives: Combination Product: Meritup oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fatigue scores
Changes in fatigue scores using the Functional Assessment of Chronic Illness Treatment (FACIT)-Fatigue subscale after 9 weeks of combined chemotherapy treatment
Measured: one months
Secondary outcomes (1)
Blood test
WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An add-on study design to assess the superiority of Meritup over placebo will be utilized in this study to evaluate whether Meritup can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Phytofound Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ming-Hsin Yeh, MD, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151249
- Sponsor's protocol ID
- CSMUH No:CS2-23089
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety and Ability of Meritup Oral Liquid to Reduce Fatigue in Patients With Metastatic Breast Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06151249
- Acronym / sponsor ID
- CSMUH No:CS2-23089
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Phytofound Biotech Co., Ltd.
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Nov 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.
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of Meritup oral solution to decrease fatigue in metastatic breast cancer patients receiving chemotherapy.
Detailed description
The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive metastatic disease and at least completed 3 cycle chemotherapy regimen who have evidence of fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An add-on study design to assess the superiority of Meritup over placebo will be utilized in this study to evaluate whether Meritup can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+Meritup | Experimental | Combination Product: Meritup oral solutionChemotherapy+Meritup 20ml TID |
| Chemotherapy+Placebo | Placebo comparator | Combination Product: Meritup oral solutionChemotherapy+Placebo 20ml TID |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients over 20years old and under 80 years old.
- Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative.
- After at least 3 cycles of chemotherapy.
- Sign the subject Informed Consent Form (ICF).
Key exclusion criteria (11 listed)
- Have received other clinical studies within 3 weeks
- Any uncontrollable infection
- History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis
- History of cancer cells that have metastasized to the brain
- Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs
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 |
|---|---|---|
| Meritup oral solutionchemotherapy + Meritup | Combination product | Chemotherapy+Meritup, Chemotherapy+Placebo |
Primary outcome
Changes in fatigue scores
Time frame: one months
Changes in fatigue scores using the Functional Assessment of Chronic Illness Treatment (FACIT)-Fatigue subscale after 9 weeks of combined chemotherapy treatment
1 secondary outcome
Blood test
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ming-Hsin Yeh, MD, PhD principal investigator
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meritup oral solution in people with Metastatic Breast Cancer, run by Chung Shan Medical University.
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 4 inclusion and 11 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 30 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Contact ChihHui Lin, MS (0935318221, wisdomli@ms2.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fatigue scores (time frame: one 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 30 Nov 2023.