PILOT STUDY OF OXCARBAZEPINE TOLEP ACTIVITY IN ANTICANCER DRUGS NEUROPHATIES - TOLMA

Conditions: europathic patients
MedDRA version: 6.1Level: PTClassification code 10034620

Registration Number: EUCTR2006-006669-17-IT

Lead Sponsor: IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 63

Inclusion Criteria

Inclusion criteria age 25-60 yrs treated with cisplatin or taxanes end of treatment since 2 weeks at least at least grade 1 neuropathy according to WHO scale life expectancy of 1 year at least
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients who, before treatment, show SNC or SNP lesions excepting paraneoplastic neuropathy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPHATY INDUCED BY TAXANES AND CISPLATIN ACCORDING TO WHO SCALE;Secondary Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPATHY INDUCED BY TAXANES AND CISPLATIN ON SUBJECTIVE SYMPTHOMS PARESTESIES, DISESTESIES, SUBJECTIVE HYPOESTHESIE NEUROLOGIC SIGNS DEEP REFLEXES, ATAXIA, ETC. ;Primary end point(s): Evaluation of patient number who after a 30 day treatment with oxcarbazepine show a decrease of 1 grade intensity of WHO scale for neuropathy

Secondary Outcome Measures