Unique ID issued by UMIN | UMIN000015872 |
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Receipt number | R000018472 |
Scientific Title | Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer. |
Date of disclosure of the study information | 2014/12/08 |
Last modified on | 2017/06/09 09:29:31 |
Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer
Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer
Japan |
Gastric cancer, breast cancer
Gastroenterology | Gastrointestinal surgery | Breast surgery |
Malignancy
NO
To evaluate the efficacy and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Proportion of patients who was improved FACT-Taxane after administering pregabalin or duloxetine.
1) Adverse effect of pregabalin and duloxetine
2) Investigation of QOL (FACT-Taxane)
3)Current perception threshold(CPT)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Pregabalin is administered 75mg bid and increased gradually 150mg bid over 1week.
Duloxetine is administered 40mg qd.
To begin administering 20mg qd, duloxetine is increased 40mg qd after an interval of more than 1 week.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who have diagnosed gastric or breast cancer by cytodiagnosis or histological diagnosis.
2) Patients who have chemotherapy -related neurotoxicity (Grade2:CTCAE v4.0) and pain.
3) ECOG PS of 0 or 1
4) Adequate function of vital organs
5) Satisfactory oral feeding
6) Written informed consent
1) Serious drug allergy
2) Active double cancer
3) Active infection
4) Serious coexisting illness
5) History of pregabalin and duloxetine treatment
6) Severe renal dysfunction
(Creatinine clearance <30mL/min)
7) Patients with using electronic implants or other cardiac pacemaker
8) Pregnant or lactating women or men who have desire father a child
9) Investigator's judgement
60
1st name | |
Middle name | |
Last name | Masashiro Goto |
Osaka Medical College Hospital
Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Masashiro Goto |
Osaka Medical College Hospital
Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
072-683-1221
in2030@poh.osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
NO
大阪医科大学付属病院(Osaka Medical College Hospital)
2014 | Year | 12 | Month | 08 | Day |
Unpublished
Completed
2014 | Year | 11 | Month | 10 | Day |
2014 | Year | 11 | Month | 10 | Day |
2014 | Year | 12 | Month | 08 | Day |
2017 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018472
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