Unique ID issued by UMIN | UMIN000014827 |
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Receipt number | R000015303 |
Scientific Title | Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC) |
Date of disclosure of the study information | 2014/08/12 |
Last modified on | 2018/02/12 09:17:39 |
Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)
NYTBC
Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)
NYTBC
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To verify whether ninjinyoeito ameriolates hematotoxicity of FEC followed by docetaxel (including anthracyclin only, or other taxanes).
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Frequency of neutropenia greater than grade 3 on day 10 of each cycle of chemotherapy
1. Use of G-CSF during the total period of chemotherapy
2. Relative dose intensity
3. Completion rate of the regimen
4. Hemoglobin concentration on day 10 of each chemotherapy cycle
5. Platelet count on day 10 of each chemotherapy cycle
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Oral administration of Tsumura Ninjinyoeito extracted granules (for ethical use) 7.5 g/day (ref: http://kconsort.umin.jp). The intervention starts on day 1, and is continued until the end of the study for 24 weeks.
Non-administration of Tsumura Ninjinyoeito extracted granules (for ethical use)
20 | years-old | <= |
80 | years-old | >= |
Female
1. Pathologically-proven breast cancer
2. No prior chemotherapy
3. Adjuvant chemotherapy
4. PS is 1.
1. Blood transfusion within 7 days of registration
2. Pleural effusion and ascites
3. Multiple cancers
4. Severe drug hypersensitivity
5. Active infection
6. Severe ECG abnormalities
7. Severe pulmonary diseases
8. Ploblematic psychiatric disorders
40
1st name | |
Middle name | |
Last name | Yoshiharu Motoo |
Kanazawa Medical University
Department of Medical Oncology
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
076-286-2211
cancer@kanazawa-med.ac.jp
1st name | |
Middle name | |
Last name | Yoshiharu Motoo |
Kanazawa Medical University
Department of Medical Oncology
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
076-286-2211
cancer@kanazawa-med.ac.jp
Department of Medical Oncology, Kanazawa Medical University
Department of Medical Oncology, Kanazawa Medical University
Self funding
NO
金沢医科大学病院(石川県)
2014 | Year | 08 | Month | 12 | Day |
Unpublished
The significance of this trial was lost due to the use of PEG-G-CSF.
Completed
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 02 | Month | 20 | Day |
2017 | Year | 08 | Month | 31 | Day |
2017 | Year | 10 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 31 | Day |
2014 | Year | 08 | Month | 11 | Day |
2018 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015303
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