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Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: Chemotherapy+Meritup
Chemotherapy+Meritup 20ml TID
Placebo Comparator: Chemotherapy+Placebo
Chemotherapy+Placebo 20ml TID
Interventions
Combination Product: - Meritup oral solution
chemotherapy + Meritup
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
ChihHui Lin, MS
[email protected]
0935318221
For additional contact information, you can also visit the trial on clinicaltrials.gov.
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