Status:
UNKNOWN
Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy
Lead Sponsor:
Chung Shan Medical University
Collaborating Sponsors:
Phytofound Biotech Co., Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
20-80 years
Phase:
PHASE2
Brief 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 ch...
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 l...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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,
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06151249
Start Date
December 1 2023
End Date
November 30 2025
Last Update
November 30 2023
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