Unique ID issued by UMIN | UMIN000011393 |
---|---|
Receipt number | R000013337 |
Scientific Title | Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin. |
Date of disclosure of the study information | 2013/08/07 |
Last modified on | 2019/02/08 14:14:34 |
Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.
Pre-XOX study
Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.
Pre-XOX study
Japan |
colorectal cancer
Gastroenterology | Hematology and clinical oncology | Adult |
Malignancy
NO
This study aim to explore the safety of lidocaine intravenous infusion for the purpose of relieving the peripheral venous pain induced by oxaliplatin, and to determine the recommended dose(RD) in the phase II study by the frequency of dose-limiting toxicity(DLT).
Safety
Exploratory
Pragmatic
Phase I
To evaluate feasibility and to determine the recommended dose
The degree of venous pain
Blood concentration of lidocaine : pharmacokinetics
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Lidocaine will be administrated continuous IV in parallel with oxaliplatin.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. Histologically proven adenocarcinoma of colorectal cancer.
2. Be to administered of more than 100 mg per sqm of oxaliplatin via peripheral vein.
3. Able to be cutdown in 22G indwelling needle in the elbow or forearm
4. Age: 20 years to 75 years
5. PS(ECOG) 0-1
6. Adequate main organ functions
7. Written informed consent by the participant
1. History of treatment with oxaliplatin
2. Pain or cutaneous symptoms in the arm
3. Unable to be self-assessment of pain
4. Contraindication for the each medicine
5. Serious abnormalty in ECG requiring treatment
6. Administration of anti-arrhythmic.
7. Administration of adjuvant analgesics in neuropathic pain
8. Sever complications
9. Pregnancy, or lactation
10. History of drug hypersenstitivity.
11. Others
12
1st name | |
Middle name | |
Last name | Miwako Uemori |
Saito Yukoukai Hospital
Department of pharmacy
7-2-18, Saito-Asagi, Ibaraki City, Osaka, Japan
+81-72-641-6898
dsakai@cfs.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Miwako Uemori |
Saito Yukoukai Hospital
Department of pharmacy
7-2-18, Saito-Asagi, Ibaraki City, Osaka, Japan
+81-72-641-6898
dsakai@cfs.med.osaka-u.ac.jp
Saito Yukokai Hospital
Saito Yukokai Hospital
Self funding
NO
2013 | Year | 08 | Month | 07 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 18 | Day |
2013 | Year | 08 | Month | 13 | Day |
2013 | Year | 08 | Month | 06 | Day |
2019 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013337
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |