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

CSMUH No:CS2-23089

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.

2023-12-01

2025-11-30

2025-11-30

Not yet recruiting

Early phase I

32

Inclusion Criteria: 1. Female patients over 20years old and under 80 years old. 2. Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor (HER2), These 3 indicators are all negative. 3. After at least 3 cycles of chemotherapy. 4. Sign the subject Informed Consent Form (ICF). Exclusion Criteria: 1. Have received other clinical studies within 3 weeks 2. Any uncontrollable infection 3. History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma or multiple sclerosis 4. History of cancer cells that have metastasized to the brain 5. Currently receiving a mixture of three or more types of cytotoxic chemotherapy drugs 6. 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, 7. Need to use long-acting sustained-release pain narcotic analgesics 8. Uncontrollable nausea, vomiting or other symptoms that will hinder the ability to speak about the test product 9. Any other serious illness/history that would limit the patient's ability to receive study treatment, as determined by the researcher evaluate 10. Lactation, pregnancy or planning pregnancy 11. People with cardiovascular disease or severe liver and kidney dysfunction should not drink it within one week after surgery.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Chemotherapy+Meritup Chemotherapy+Placebo', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

2023-11-30