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Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer

Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer - Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010621
Enrollment
20
Registered
2013-07-02
Start date
2013-05-01
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

advanced colorectal cancer

Interventions

duloxetine

Sponsors

Osaka City General Hospital Department of Clinical Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age>=20years 2) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer) 3)Gr1 peripheral neuropathy 4) ECOG performance status 0-2. including cetuximab, or panitumumab 5)Adequate hematologic, renal, hepatic and metabolic function : 6) Written informed consent obtained from the patient

Exclusion criteria

Exclusion criteria: 1)having other active malignancies 2) severe complications (uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, heart failure ,renal failure, hepatic failure, etc.) 3) having active infections 4) history of severe drug hypersensitivity 5) uncontrollable serious mental problem 7) pregnant or female intend to be pregnant, and male intend to make pregnant. 8) peripheral neuropathy>=Gr2 9)Others

Design outcomes

Primary

MeasureTime frame
prolongation of period of oxaliplatin treatment

Secondary

MeasureTime frame
safety

Countries

Japan

Contacts

Public ContactKoichi Taira

Osaka City General Hospital Department of Clinical Oncology

koichit@iris.eonet.ne.jp

Outcome results

None listed

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