Taxanes- or platinum-induced neuropathy Nervous System Diseases Taxanes- or platinum-induced neuropathy
Conditions
Interventions
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
vibration examination
total neuropathy score (TNS)
electroneurography (ENG).
Safety:
Physical examinations, electrocardiograms (ECGs), vital signs, laboratory tests, adverse events and concomitant medications will be considered for the safety and tol
Sponsors
Sigma-Tau (Italy)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium, France, Italy
Outcome results
None listed