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Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.

Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin. - Pre-XOX study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011393
Enrollment
12
Registered
2013-08-07
Start date
2013-08-13
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

Lidocaine will be administrated continuous IV in parallel with oxaliplatin.

Sponsors

Saito Yukokai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To evaluate feasibility and to determine the recommended dose

Secondary

MeasureTime frame
The degree of venous pain Blood concentration of lidocaine : pharmacokinetics

Countries

Japan

Contacts

Public ContactMiwako Uemori

Saito Yukoukai Hospital Department of pharmacy

dsakai@cfs.med.osaka-u.ac.jp+81-72-641-6898

Outcome results

None listed

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