Randomized phase II study of adding tramadol for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein

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]

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018059

Enrollment

Registered

2015-06-24

Start date

2014-06-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
VRS improvement rate	—

Countries

Japan

Contacts

Public ContactKeiko Kamei

Kinki University Faculty of Medicine Department of Surgery

keiko-kamei@surg.med.kindai.ac.jp072-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026