Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Phytofound Biotech Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+Meritup | Experimental | Chemotherapy+Meritup 20ml TID |
|
| Chemotherapy+Placebo | Placebo Comparator | Chemotherapy+Placebo 20ml TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meritup oral solution | Combination Product | chemotherapy + Meritup |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood test | WBC, RBC, PLT, serum creatinine (SCr), SGOT, SGPT | one month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChihHui Lin, MS | Contact | 0935318221 | wisdomli@ms2.hinet.net |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Hsin Yeh, MD, PhD | Chung Shan Medical University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Chemotherapy+Meritup Chemotherapy+Placebo
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |