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

ISRCTN	ISRCTN85659215
DOI	https://doi.org/10.1186/ISRCTN85659215
Protocol serial number	ST200-DM-04-005
Sponsor	Sigma-Tau (Italy)
Funder	Sigma-Tau i.f.r. S.p.A. (Italy) (Protocol ref: ST200-DM-04-005)

Submission date: 24/05/2005
Registration date: 02/08/2005
Last edited: 19/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Massimo Ildebrando
Scientific

Via Pontina km 30,400
Pomezia (Rome)
00040
Italy

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The clinical hypothesis to be verified is 20% response rate in the placebo group versus 40% response rate in the Acetyl-L-Carnitine group where a responder is defined as a patient having obtained a decrease of at least one grade in the NCI-CTC sensory score at treatment end as compared to baseline. Please note that this record was updated on 05/11/2007. Changes were made to the countries of recruitment, the inclusion criteria, and the anticipated end date. The previous end date for this trial was 31/12/2006.
Ethics approval(s)	Ethics approval received from the following ethics committees: 1. Università degli Studi G. d'Annunzio on the 21st July 2005 2. Direzione Sanitaria del P.O.S. Gerardo on the 16th September 2005 3. Presidio Arcispedale Santa Maria Nuova on the 9th September 2005 4. dell'A.U.S.L. Roma H on the 19th September 2005 5. Servizio di Farmacia on the 26th September 2005 6. Segreteria del Comitato Etico on the 15th September 2005 7. Comitato Etico per la Sperimentazione clinica dei medicinalion the 6th February 2006 8. Commessione Etico-Scientifica - ASL Rimini on the 12th October 2005 9. Istituto Nazionale per lo Studio e la Cura dei Tumori on the 20th February 2006
Health condition(s) or problem(s) studied	Taxanes- or platinum-induced neuropathy
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Acetyl-L-Carnitine (ST 200)
Primary outcome measure(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.
Key secondary outcome measure(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.
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	172
Key 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.
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Belgium
France
Italy

Study participating centre

Via Pontina km 30,400

Pomezia (Rome)
00040
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan