Unique ID issued by UMIN | UMIN000016681 |
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Receipt number | R000019357 |
Scientific Title | Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer |
Date of disclosure of the study information | 2015/03/02 |
Last modified on | 2019/04/23 09:46:35 |
Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea
Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea
Japan |
cervical cancer
Obstetrics and Gynecology |
Malignancy
NO
The aim of this study is to investigate the efficacy and safety of Goreisan for preventing diarrhea during radiation therapy in patients with cervical cancer.
Safety,Efficacy
Occurrence rate of >grade 2 diarrhea as measured by the Common Terminology Criteria for Adverse Events v4.0.
1) Protection period of diarrhea (total treatment duration - total days of >grade 2 diarrhea / total treatment duration);
2) Time to the first occurrence of >grade 2 diarrhea from the first day of treatment;
3) Adverse effects;
4) Frequency of diarrhea and transition of the grade of diarrhea.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Goreisan 7.5g per day
20 | years-old | < |
70 | years-old | > |
Female
1) Histologically confirmed uterine cervical cancer of clinical stage IB2-IVa in whom cisplatin-based CCRT was planned as both primary and adjuvant treatments
2) Age >20 years, <75 years;
3) Performance status =<2;
4) With written informed consent obtained before participation;
5) No prior radiother
1) Inflammatory bowel disease such as Crohn disease and ulcerative colitis
2) Severe hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase >=100 U/L)
3) Severe renal dysfunction (serum creatinine >=1.5 mg/dL or blood urea nitrogen >=25 mg/dL)
4) Mental illness that may require the administration of antipsychotics, and dementia
5) Current use of other oriental medicine
6) A history of the hypersensitivity that is serious for the study medicine, or drug allergy
7) Any case that the chief physician judges to be inadequate.
40
1st name | AKIRA |
Middle name | |
Last name | Mitsuhashi |
Graduate School of Medicine, Chiba University
Reproductive Medicine
260-8670
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
043-222-7171
antira@faculty.chiba-u.jp
1st name | Sinsuke |
Middle name | |
Last name | Hanawa |
Chiba University Hospital
Gynecology
260-8670
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
043-222-7171
hanawa-shinsuke@chiba-u.jp
Chiba University Hospital
none
Other
Chiba University Hospital Institutional Review Board
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
043-222-7171
hanaoka.hideki@faculty.chiba-u.jp
NO
2015 | Year | 03 | Month | 02 | Day |
Unpublished
Terminated
2014 | Year | 10 | Month | 19 | Day |
2014 | Year | 12 | Month | 17 | Day |
2015 | Year | 03 | Month | 02 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 02 | Day |
2019 | Year | 04 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019357
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