Unique ID issued by UMIN | UMIN000014857 |
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Receipt number | R000017267 |
Scientific Title | Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer |
Date of disclosure of the study information | 2014/09/01 |
Last modified on | 2014/08/13 18:30:40 |
Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Clinical study of TJ-14 for oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Clinical study of TJ-14 for oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Japan |
Head and neck malignant cancer
Oto-rhino-laryngology |
Malignancy
NO
To evaluate preventive effects of TJ-14 for oral mucositis related to chemotherapy and radiotherapy.
Efficacy
The inflammatory marker (IL-1, TNF-alpha, PGE2), oxidant stress marker (8-OHdG, AGEs, 8-isoprostane), antioxidant biomarker [SOD, TAC(total antioxidant capacity)]
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Oral administration of TJ-14 7.5g/day between meals.
Oral administration of placebo 7.5g/day between meals.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with radiation or chemotherapy for head and neck cancer
Patients that oral care is possible
Performance status of 0 or 1
Patients that communication is possible
Patients have adequate function of vital organ
Patients provide written informed consent before initiation of study
Patients that had used Kampo medicine within 1 month before registration
Patients that have an allergy for TJ-14
Patients that don't hope for participation in this study
Interruption of the treatment over 1 month
Serious psychiatric disorder
Patients that will be inappropriate for entry into this study in the judgment of the investigator.
20
1st name | |
Middle name | |
Last name | Kenkichiro Taira |
Tottori University Hospital
Depertment Otolaryngology:Head and Neck surgery
Nishimachi 36-1, Yonago, Tottori, Japan
0859-38-6627
kenkichiro.t@med.tottori-u.ac.jp
1st name | |
Middle name | |
Last name | Kenkichiro Taira |
Tottori University Hospital
Depertment Otolaryngology:Head and Neck surgery
Nishimachi 36-1, Yonago, Tottori, Japan
0859-38-6627
kenkichiro.t@med.tottori-u.ac.jp
Tottori University Hospital
Tottori University Hospital
Other
NO
2014 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2014 | Year | 07 | Month | 10 | Day |
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 08 | Month | 13 | Day |
2014 | Year | 08 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017267
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