Prevention of Oxaliplatin Induced Peripheral Neuropathy (OIPN)

Efficacy of Duloxetine for the prevention of Oxaliplatin Induced Peripheral Nephropathy (OIPN)- A double blinded placebo controlled phase 2 study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170211032494N2

Enrollment

Registered

2019-01-04

Start date

2016-07-22

Completion date

Unknown

Last updated

2019-01-29

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

Conditions

Oxaliplatin Induced Peripheral Neuropathy (OIPN). Other anti neoplastic drugs

Interventions

Intervention 1: Intervention group: Duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) was given 60 mg once a day orally from the first day to the day 14 of each cycle

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients have pathologically confirmed cancer; Aged 18-75; Candidate for receiving at least 4 courses of Oxaliplatin; Good performance status (based on ECOG)

Exclusion criteria

Exclusion criteria: History of diabetes mellitus; Previous neuropathy; Chronic renal or liver disease; Consumption of neurotoxic/neurotropic/neuroleptic drugs

Design outcomes

Primary

Measure	Time frame
Oxaliplatin Induced Peripheral Neuropathy (OIPN). Timepoint: Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle. Method of measurement: Subjective evaluation by Common Terminology Criteria for Adverse Effect, Objective assessment by Nerve Conducting Study.	—

Secondary

Measure	Time frame
Safety profile of Duloxetine. Timepoint: Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Nousavi Darzikolaee

Radiation Oncology Research Center, Cancer Institute , Imam Khomeini Hospital Complex

mousavi.nima@yahoo.com+98 21 6694 8679

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026