Evaluation of Acetyl-L-Carnitine (ST 200) to reduce intensity of taxanes- or platinum-induced sensory neuropathy

Completed

Conditions: Taxanes- or platinum-induced neuropathy
Nervous System Diseases

Registration Number: ISRCTN85659215

Lead Sponsor: Sigma-Tau (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 172

Inclusion Criteria

Current inclusion criteria as of 05/11/2007:
Patients (male and female aged 18 or more years and Karnofsky greater than 60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.

Previous inclusion criteria:
Patients (male and female age between 18 and 70 years and Karnofsky >60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.

Exclusion Criteria

1. Pre-existing neuropathies of different origin than those considered in this trial
2. Diabetes mellitus, insulin-dependent
3. Symptomatic brain metastases
4. Leptomeningeal involvement
5. Significant infective ilness or active inflamed focus
6. Concomitant therapy with other neuroprotective agents
7. Any previous use of neuro-protectant drugs if performed from the last chemoteraphy administration, onwards
8. Any neurotoxic chemotherapy since one month prior to baseline
9. Predictable lack of patient's co-operation
10. Pregnancy, nursing, or women of childbearing potential not using an effective method of birth control
11. Previous treatment with platinum for those patients who enter the study due to taxanes-induced sensory neuropathy
12. Previous treatment with taxanes for those patients who enter the study due to platinum-induced sensory neuropathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensory item of NCI-CTC version 3.0 dated December 12th 2003 will be the primary endpoint. In accordance with the primary objective of the study, the proportion of responder patients measured at treatment end (i.e. visit 2) will be the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
1. Motor item of NCI-CTC version 3.0<br>2. Ulnar, sural and common peroneal nerve conduction velocity (NCV)<br>3. Symptoms/signs of peripheral damage<br>4. Vibration perception threshold<br>5. Total neuropathy score (TNS)<br>6. Plasma NGF level<br>All the variables will be descriptively analysed by treatment and visit (mean, median, standard deviation, minimum and maximum for continuous variables, frequency distribution for categorical variables). Efficacy analysis will be applied in all populations. Results from the ITT population will be considered the primary ones.<br>