Unique ID issued by UMIN | UMIN000020383 |
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Receipt number | R000023499 |
Scientific Title | Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer |
Date of disclosure of the study information | 2015/12/29 |
Last modified on | 2019/06/21 09:31:05 |
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer
Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer
Japan |
Digestive cancer
Gastroenterology |
Malignancy
NO
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
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine | Maneuver |
Oral administration of Hangeshashinto 7.5g/day t.i.d. before meals.
No take Hangeshashinto.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with digestive cancer who undergo 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 and < 12,000/mm3
2) Neutrophil count > 1,500/mm3
3) Platelet count > 10.0 X 10^4/mm3
4) AST,ALT > normal limit X 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@osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Takayuki Kii |
Osaka Medical College Hospital
Cancer Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
072-683-1221
in2058@osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
Japanese
NO
大阪医科大学附属病院(大阪府)
2015 | Year | 12 | Month | 29 | Day |
Unpublished
Completed
2015 | Year | 08 | Month | 04 | Day |
2015 | Year | 11 | Month | 02 | Day |
2016 | Year | 01 | Month | 05 | Day |
2018 | Year | 06 | Month | 20 | Day |
2015 | Year | 12 | Month | 28 | Day |
2019 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023499
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