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Studying the effect of duloxetine on neuropathy caused by platinum-based chemotherapy drugs

A Double-Blind Randomized Clinical Trial to Evaluate the Efficacy of Duloxetine Prophylaxis on the rate of Neuropathy in Patients with Malignancy Receiving Platinum-Based Chemotherapy Regimens

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250909067196N1
Enrollment
100
Registered
2026-01-24
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

platin Base chemotherapy Regimes Induced neuropathy. Drug-induced polyneuropathy

Interventions

Intervention 1: Intervention group: Receiving Deluxetine. Intervention 2: Control group: Receiving Placebo.

Sponsors

Artesh University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years old Confirmation of cancer diagnosis Written consent from the patient No history of duloxetine use The chemotherapy regimen contains platinum.

Exclusion criteria

Exclusion criteria: The participant's unwillingness to start or continue cooperation Severe side effects from taking duloxetine, such as severe nausea, excessive drowsiness, increased blood pressure, or psychotic symptoms. Intolerance to medication or failure to take it regularly as prescribed by the doctor, including frequent forgetting to take it or arbitrarily stopping the medication. A change in the patient's clinical condition that makes it impossible to continue the study, such as prolonged hospitalization, change in chemotherapy regimen, or the development of new diseases. Failure to attend follow-up sessions or periodic assessments if the participant misses more than two assessment sessions. Taking medications that interact with duloxetine during the study, such as MAO inhibitors or other antidepressants that are prohibited in the protocol. Initial misdiagnosis or failure to meet inclusion criteria after further review, such as diagnosis of a different type of cancer or a history of prior neuropathy that was not initially reported. Evidence of neuropathy or diseases that cause neuropathy by themselves prior to study entry Renal disorders that have occurred in the patient Not receiving chemotherapy

Design outcomes

Primary

MeasureTime frame
Neuropathy. Timepoint: each 2 or 3 weeks. Method of measurement: questionnaire and physical examination.

Secondary

MeasureTime frame
Severity of neuropathy. Timepoint: each 2 or 3 weeks. Method of measurement: questionnaire and physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmehrpouya mashhadizadeh

Artesh University of Medical Sciences

mehrpouya.mashhadizadeh@gmail.com+98 939 637 8058

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026