Evaluate the Meritup Oral Solution to Decrease Fatigue in Metastatic Breast Cancer Patients Receiving Chemotherapy

Study Overview
=================
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 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.

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

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Combination Product: Meritup oral solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy+Meritup<br>Chemotherapy+Meritup 20ml TID | Combination Product: Meritup oral solution<br>* chemotherapy + Meritup<br>|
| Placebo Comparator: Chemotherapy+Placebo<br>Chemotherapy+Placebo 20ml TID | Combination Product: Meritup oral solution<br>* chemotherapy + Meritup<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood test | WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer, Fatigue