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Evaluation of Duloxetine effect on Oxaliplatin induced peripheral neuropathy prophylaxis

Evaluation of Duloxetine effect on Oxaliplatin induced peripheral neuropathy prophylaxis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100127003210N15
Enrollment
40
Registered
2018-06-25
Start date
2017-02-19
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

colorectal cancer. malignant neoplasm of colon

Interventions

Intervention 1: Intervention group: patient who take duloxetine 30mg/d for first week and then 30 mg BD to 12 weeks. Intervention 2: Control group: Patients in this group receive one placebo capsule d

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years old The candidate patient is going to get his/her first chemotherapy course with Oxaliplatin drug

Exclusion criteria

Exclusion criteria: The patient has no uncontrolled diabetes mellitus or uncontrolled hypertension The patient is not taking drugs which have interaction with Duloxetin The patient is not on liver metastatic stage History of duloxetine allergy hepatic impairment clcr < 30ml/min and ESRD

Design outcomes

Primary

MeasureTime frame
Peripheral neuropathy. Timepoint: every 2-3 week. Method of measurement: FACT/GOG-NTX-13 and NCI-CTCAE questionaire.

Secondary

MeasureTime frame
Quality of life. Timepoint: at baseline and 12 weeks later. Method of measurement: FACT-C version 4 questionaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRokhsareh Soufi

Shahid Beheshti University of Medical Sciences

rokhsareh_soufi@yahoo.com+98 21 8820 0118

Outcome results

None listed

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