To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area

To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area - To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area : HARUKA study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010438

Enrollment

120

Registered

2013-04-08

Start date

2013-04-15

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

Pregabalin is administered during FOLFOX therapy. Initial dose:75mg twice daily(150mg/day),possible to increase the dose 300mg/day(maximam dose). only mFOLFOX6 administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent 2)Patients who is judged by investigator to be able to receive the protocol therapy 3)Patients with histologically proven colorectal cancer and lower edge of tumor located upper than Douglas pouch 4)p-Stage2,3a,3b 5)R0 (Curability A) 6)Age; 20<=, <=80 7)ECOG performance status 0-1 8)within 8 weeks from operation 9) Patiens have enough organ function based on blood test 1.WBC>=3,000-<=12,000/mm3, 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6.AST<=100U/L 7.ALT<=100U/L 8. Creatinine>=30ml/minute

Exclusion criteria

Exclusion criteria: 1)transfusion, G-CSF etc. within 7days 2)severe allergic reaction 3)peripheral neuropthy 4)Simultaneous or metachronous double cancers 5)Active infectious disease 6)Severe mental disease 7)Grade2+, diarrhea 8)systemic administration of corticosteroids 9)Pregnant or lactating women or women of childbearing potential 10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc) 11)AMI within 6 months 12)History of transplantation 13)Preoperative therapy for CRC 14)History of colostomy 15)Unhealing of post-operative complication 16)Gashajinkigan, or drug for neuropathy 17)Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Time to neuropathy(grade<2:CTCAEv4.0)	—

Countries

Japan

Contacts

Public ContactHisashi Nagahara

Osaka City University Graduate School of Medicine Department of Surgical Oncology

Outcome results

None listed

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