Unique ID issued by UMIN | UMIN000010988 |
---|---|
Receipt number | R000012862 |
Scientific Title | The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy. |
Date of disclosure of the study information | 2013/06/18 |
Last modified on | 2021/12/20 15:20:31 |
The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
The efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
The efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Japan |
chemotherapy-induced peripheral neuropathy
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
NO
Efficacy of goshajinkigan and lafutidine for chemotherapy-induced peripheral neuropathy
Safety,Efficacy
Phase III
The level of improvement of peripheral neuropathy is evaluated by Visual Analogue Scale (VAS).
Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
Lafutidine is administered orally at the dose of 10 mg twice daily for 8 weeks.
Goshajinkigan is administered orally at the dose of 2.5g three times daily for 8 weeks.
20 | years-old | <= |
Not applicable |
Female
1)Breast cancer patient with taxane-induced peripheral neuropathy, which continued more than 1 month after chemotherapy with taxane (paclitaxel, nab-paclitaxel, docetaxel).
2)with residual peripheral neuropathy in spite of mecobalamin administered
3)with digestive symptom such as upper abdominal discomfort
4)written informed consent
1)not mecobalamin administered
2)with severe complications (such as liver failure, renal failure, heart failure)
3)with history of allergy
4)alredy adminstered with Goshajinkigan, Mecobalamin or Lafutidine.
5)with peripheral neuropathy for other cause (such as diabetes)
6)receiving drugs to influence peripheral neuropathy
7)doctore's decision not to be registered to this study
35
1st name | |
Middle name | |
Last name | Masahiro Kishimoto |
Meiwa Hospital
Department of breast and endocrine surgery
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, in Japan
0798-47-8186
mm-kishi@hotmail.co.jp
1st name | |
Middle name | |
Last name | Masahiro Kishimoto |
Meiwa Hospital
Department of breast and endocrine surgery
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, in Japan
0798-47-8186
mm-kishi@hotmail.co.jp
Department of breast and endocrine surgery, Meiwa Hospital
None
Self funding
NO
2013 | Year | 06 | Month | 18 | Day |
Unpublished
Terminated
2013 | Year | 02 | Month | 04 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2013 | Year | 06 | Month | 18 | Day |
2021 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012862
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |