EVALUATION OF ACETYL -L-CARNITINE (ST 200) TO REDUCE INTENSITY OF TAXANES- OR PLATINUM-INDUCED SENSORY NEUROPATHY

Conditions: Peripheral neurophaty in cancer patients previously treated with taxanes- or platinum-based chemotherapy
MedDRA version: 7.0Level: HLGTClassification code 10027655

Registration Number: EUCTR2005-000004-13-BE

Lead Sponsor: Sigma-Tau i.f.r. S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 172

Inclusion Criteria

- Male and female age >/= 18 years;
- Written informed consent;
- Karnofsky > 60;
- Life expectancy >/= 6 months;
- Adequate organ functions defined as follows:
- absolute neutrophil count >/= 1.0 *10^9 L
- platelet count >/= 75.0 *10^9 L
- serum creatinine level < 3 x UNL
- alkaline phosphatase - taxanes- or platinum-induced sensory peripheral neuropathy grade 2 or 3, according to the sensory item of NCI-CTC version 3.0, at least 1 month after neurotoxic (taxanes or platinum-based) chemotherapy for cancer treatment discontinuation.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pre-existing neuropathies of different origin than those considered in this trial;
- diabetes mellitus, insulin-dependent;
- symptomatic brain metastases;
- leptomeningeal involvement;
- significant infective illness or active inflamed focus;
- concomitant therapy with other neuroprotective agents (for details, see section 5.5 of the protocol);
- any previous use of neuro-protectant drugs (such as sodium thiosulphate, glutathione, amifostine, gabapentin, lamotrigine, glutamic acid, ACTH analogues, neuronal growth factors, Vitamin E) if performed from the last chemotherapy administration, onwards;
- any neurotoxic chemotherapy since one month prior to baseline;
- predictable lack of patient’s co-operation;
- pregnancy, nursing, or women of childbearing potential not using an effective method of birth control;
- concomitant use of both platinum and taxane in the same line chemotherapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to evaluate the efficacy of ALC in reducing the intensity of taxanes- or platinum-induced sensory neuropathy in cancer patients.;Secondary Objective: The secondary objectives are to evaluate:<br>- Motor item of NCI-CTC version 3.0<br>- ulnar, sural and common peroneal nerve conduction velocity (NCV);<br>- symptoms/signs of peripheral damage;<br>- vibration perception threshold;<br>- total neuropathy score, TNS;<br>- plasma NGF level.<br>;Primary end point(s): The sensory item of NCI-CTC version 3.0 December 12th, 2003 will be the primary endpoint.

Secondary Outcome Measures