Unique ID issued by UMIN | UMIN000019664 |
---|---|
Receipt number | R000022724 |
Scientific Title | Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer |
Date of disclosure of the study information | 2015/11/06 |
Last modified on | 2019/06/21 09:27:18 |
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer
Japan |
Breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
YES
Efficacy
Safety
DTM:Duration time of oral mucositis for 21 days
Incidence of oral mucostis, Incidence of diarrhea, Blood level of CRP, Change of body weight and blood level of albumin
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine | Maneuver |
Oral administration of Hangeshashinto 7.5g/day t.i.d. before meals or between meals.
No take Hangeshashinto.
20 | years-old | <= |
Not applicable |
Female
1. Patients with breast cancer who wndergo chemotherapy
2. Patients with oral mucositis caused by prior chemotherapy
3. ECOG Performance status:0-1
4. Over 20 years old female
5. Patients who maintain main organs function
1 White blood cells count >2,500/mm3
2 Neutrophil count >1,500/mm3
3 Platelet count > 10.0*10^4/mm3
4 AST,ALT> normal limit * 2.5
5 Serum total bilirubin< normal limit X 1.5
6 Serum creatinine < normal limit
6. Written informed consent
1. Patients who receives a medical prescription of herbal medicine within 2 weeks before registration of the final examination
2. Patients with the past of severe medicine hyperesthesia or severe drug allergy
3. Anti-inflammation anodyne medicine, OPIOIDO or the patient who has a medical treatment by a steroid
4.Sense unusualness or perception, some incomplete patients
5. Patients with active double cancer
6. Patients with serious heart diseases
7. Patients with serious lung diseases
8. Patients with serious constipation
9. Pregnant woman, lactating woman and patient with a possibility of the pregnancy
50
1st name | |
Middle name | |
Last name | Masahiro Gotoh |
Osaka Medical College Hospital
Cancer Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
072-683-1221
in2030@poh.oasaka-med.ac.jp
1st name | |
Middle name | |
Last name | Mitsuhiko Iwamoto |
Osaka Medical College Hospital
Department of Breast Surgery
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
072-683-1221
sur067@poh.osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
NO
2015 | Year | 11 | Month | 06 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 10 | Day |
2015 | Year | 01 | Month | 05 | Day |
2015 | Year | 11 | Month | 16 | Day |
2017 | Year | 06 | Month | 02 | Day |
2015 | Year | 11 | Month | 06 | Day |
2019 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022724
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |