Unique ID issued by UMIN | UMIN000018059 |
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Receipt number | R000020910 |
Scientific Title | Randomized phase II study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein |
Date of disclosure of the study information | 2015/06/24 |
Last modified on | 2015/06/24 13:09:47 |
Randomized phase II study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein
Randomized phaseII study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein [PATRAX study]
Randomized phase II study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein
Randomized phaseII study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein [PATRAX study]
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate effect of combined administration of tramadol and oxaliplatin on peripheral venous pain
Safety,Efficacy
VRS improvement rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
oxaliplatin 130mg/m2 day1
oral 5FU 80-120mg/m2 day1-14
every 3weeks
Tramadol is given orally at a dose of 25mg once a day starting on the day of oxaliplatin infusion.
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically confirmed colorectal cancer
2.Oxaliplatin administration by peripheral vein
3.age; more than 20 years old
4.PS(ECOG);0,1
5.adequate oral intake
6.sufficient functions of major organ
7.having written informed consent
1.case with the history of usage of the oxaliplatin
2.severe drug hypersensitivity
3.neuropathy or sensory dysfuncion
4.pain in the arm
5.current analgesic treatment
6.severe infection
7.with severe psychological symptoms
8.cases with any of the complications and symptioms of the following
*with uncontrollable diabetes
*with uncontrollable hypertention
*intestitial pneumonia or pulmonary
*with intestinal paralysis,ileus
*with uncontrollable heart disease
9.inappropriate patients for entry on this study in the judgment of the investigator
30
1st name | |
Middle name | |
Last name | Kiyotaka Okuno |
Kinki University Faculty of Medicine
Department of Surgery
377-2 Ohno-higashi Osakasayama City OSAKA
072-366-0221
okuno@surg.med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Keiko Kamei |
Kinki University Faculty of Medicine
Department of Surgery
377-2 Ohno-higashi Osakasayama City OSAKA
072-366-0221
keiko-kamei@surg.med.kindai.ac.jp
Kinki University Faculty of Medicine
none
Self funding
NO
2015 | Year | 06 | Month | 24 | Day |
Unpublished
Open public recruiting
2014 | Year | 04 | Month | 09 | Day |
2014 | Year | 06 | Month | 10 | Day |
2015 | Year | 06 | Month | 24 | Day |
2015 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020910
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