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Investigating the effect of Duloxetine on improving polyneuropathy

Study of effectiveness of Duloxetine in improving symptoms of chemotherapy induced polyneuropathy by vincristine in children with cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230626058586N8
Enrollment
56
Registered
2024-11-18
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Polyneuropathy. Drug-induced polyneuropathy

Interventions

Intervention 1: Intervention group: Duloxetine drug is prescribed as 20 mg once a day and after two weeks the dose is increased to 40 mg a day. Intervention 2: Control group: Capsule containing starch

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Signing the informed consent form of all the parents of the patients participating in this study regarding their participation in this study according to the approved protocol and the implementation of all orders and follow-ups. Patients with an age range between 5 and 18 years Cancer patients treated with vincristine Patients with cancer treated with vincristine who have complications and clinical symptoms of CIPN according to the clinical diagnosis of the relevant oncologist

Exclusion criteria

Exclusion criteria: The presence of other underlying polyneuropathies according to a normal basal muscle nerve strip CNS tumors Any cognitive disorder in patients with unstable medical condition Impaired vital signs at the time of assessment and muscle strip testing Consumption of nifedipine, cyclosporine, carbamazepine, phenytoin, HCSF, vitamin E, B6, B12, omega 3 and herbal medicines by the patient. Intolerance of the drug by the patient and declaration of non-cooperation

Design outcomes

Primary

MeasureTime frame
The amount of neuropathy symptoms. Timepoint: After two months and also after six months from the start of the intervention. Method of measurement: Pediatric modified total neuropathy score questionnaire.;Examining emotional and behavioral symptoms. Timepoint: After two months and also after six months from the start of the intervention. Method of measurement: by the Strengths and Difficulties Questionnaire.;Examining the sensory function of nerves. Timepoint: After two months and also after six months from the start of the intervention. Method of measurement: by electro-diagnosis.

Secondary

MeasureTime frame
Occurrence of drug side effects (nausea and vomiting). Timepoint: Two months later and six months after the beginning of the intervention. Method of measurement: Questionnaire of occurrence of drug side effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Babaee

Shahid Beheshti University of Medical Sciences

rambabaee@yahoo.com+98 21 2222 7021

Outcome results

None listed

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