The effectiveness of doxepin in comparison with duloxetin in the treatment of chemotherapy-induced peripheral neuropathy

Investigating the effectiveness of doxepin in comparison with duloxetin in the treatment of chemotherapy-induced peripheral neuropathy (CIPN): a randomized, double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240721062502N2

Enrollment

Registered

2025-02-09

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

chemotherapy-induced peripheral neuropathy (CIPN). Drug-induced polyneuropathy

Interventions

Intervention 1: Intervention group: Razak Company's Doxepin will be administered orally at a dose of 10 mg daily from the time of diagnosis of chemotherapy-induced neuropathy in patients, and if the p

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of chemotherapy-induced peripheral neuropathy after receiving chemotherapy The patient must be 18 years of age or older. The patient must be able to swallow. Confirmation of chemotherapy-induced peripheral neuropathy based on EMGNCV results Consent of the patient or the patient's legal guardian to participate in the study

Exclusion criteria

Exclusion criteria: Patients who have a history of allergy to Doxepin or any of the components of its capsule Patients with EMGNCV results indicating neuropathy due to reasons other than chemotherapy Patients with a previous diagnosis of megaloblastic anemia Patients with a previous diagnosis of radiculopathy Pregnant and breastfeeding women Patients with diabetic neuropathy or a history of other causes of neuropathy Patients who, prior to the start of the study, were taking medications such as vitamin E, gabapentin, nortriptyline, amitriptyline, duloxetine, or other medications that have limited effects on improvement of chemotherapy-induced neuropathy Patients with a history of glaucoma Patients with sleep apnea Patients with a history of seizures Patients with benign prostatic hyperplasia or any other disease leading to urinary retention Patients with a history of syncope or persistent hypotension

Design outcomes

Primary

Measure	Time frame
Pain intensity. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: Visual analogue scale.;Quality of life. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: EORTC-C30 questionnaire.;Neuropathic condition. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: Douleur Neuropathique 4 (DN4) questionnaire and EORTC-CIPN-20 questionnaire.;Severity of neuropathy. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: NCI-CTCAE criteria and EMGNCV.	—

Measure

Time frame

Pain intensity. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: Visual analogue scale.;Quality of life. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: EORTC-C30 questionnaire.;Neuropathic condition. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: Douleur Neuropathique 4 (DN4) questionnaire and EORTC-CIPN-20 questionnaire.;Severity of neuropathy. Timepoint: At the beginning of the study and 3 months after the start of the study. Method of measurement: NCI-CTCAE criteria and EMGNCV.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDena Firouzabadi

Shiraz University of Medical Sciences

denaf9@yahoo.com+98 71 3242 4128

Outcome results

None listed

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