Peripheral Sensory Neuropathy
Conditions
Keywords
Chemotherapy-induced peripheral neuropathy (CIPN)
Brief summary
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
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.
Interventions
DRUGAcetylcarnitine
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
DRUGPlacebo
3 t.i.d, two plates per time
Sponsors
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Weeks to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in peripheral sensory neuropathy grades | Base and eighth week | Changes in peripheral sensory neuropathy grades after eight weeks treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Neuroelectrophysiological test | Base and eighth week | Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment |
| Changes in Cancer-related fatigue level | Base and eighth week | Changes in Cancer-related fatigue level after eigth weeks treatment |
| Changes in Physical Condition Score | Base and eighth week | Changes in Physical Condition Score after eight weeks treatment |
Outcome results
None listed