Clinical Study on Acetyl-L-Carnitine

Study Overview
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Brief Summary
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Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

Detailed Description
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This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Official Title
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Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce

Conditions
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Peripheral Sensory Neuropathy

Intervention / Treatment
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* Drug: Acetylcarnitine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had signed the Informed Consent Form Male or Female Age 18-75 years old Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was >/=grade 3 or grade 2 lasting for one month The course of neuropathy was </=6 months No need to continue chemotherapy according to the condition nor refusing chemotherapy At least one of the neuroelectrophysiological examine results were abnormal Physical Condition Score (KPS) >/=60 Anticipated lifetime>/=60. Exclusion Criteria: Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics Diabetics Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days Patients had treated by other clinical trial medicines or participated into other trials in 30 days Patients had active infections Any clinical problems out of control Women in pregnancy and lactation, Subjects with no compliance.

Ages Eligible for Study
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Minimum Age: 18 Weeks
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALC<br>ALC | Drug: Acetylcarnitine<br>* Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or >4 hours for 8 weeks<br>* Other names: NICETILE;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 t.i.d, two plates per time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in peripheral sensory neuropathy grades | Changes in peripheral sensory neuropathy grades after eight weeks treatment | Base and eighth week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neuroelectrophysiological test | Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment | Base and eighth week | 
| Changes in Cancer-related fatigue level | Changes in Cancer-related fatigue level after eigth weeks treatment | Base and eighth week | 
| Changes in Physical Condition Score | Changes in Physical Condition Score after eight weeks treatment | Base and eighth week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy-induced peripheral neuropathy (CIPN)