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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN85659215
• Date of registration: 02/08/2005
• Prospective Registration: No
• Primary sponsor: Sigma-Tau (Italy)
• Public title: Evaluation of Acetyl-L-Carnitine (ST 200) to reduce intensity of taxanes- or platinum-induced sensory neuropathy
• Date of first enrolment: 01/07/2005
• Target sample size: 172
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN85659215
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

Belgium, France, Italy

Contacts

• Name: Massimo Ildebrando

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Placebo versus Acetyl-L-Carnitine.

Efficacy:
Neuropathy will be assessed by a neurologist at each study visit using: sensory and motor items of National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 3.0; vibration examination; total neuropathy score (TNS); clinical neurological evaluation; electroneurography (ENG).

Safety:
Physical examinations, electrocardiograms (ECGs), vital signs, laboratory tests, adverse events and concomitant medications will be considered for the safety and tolerability evaluation.

Primary Outcome(s)

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(s)

1. Motor item of NCI-CTC version 3.0
2. Ulnar, sural and common peroneal nerve conduction velocity (NCV)
3. Symptoms/signs of peripheral damage
4. Vibration perception threshold
5. Total neuropathy score (TNS)
6. Plasma NGF level
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.

Secondary ID(s)

ST200-DM-04-005

Source(s) of Monetary Support

Sigma-Tau i.f.r. S.p.A. (Italy) (Protocol ref: ST200-DM-04-005)