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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
239
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
3 t.i.d, two plates per time
Changes in peripheral sensory neuropathy grades
Changes in peripheral sensory neuropathy grades after eight weeks treatment
Time frame: Base and eighth week
Changes in Neuroelectrophysiological test
Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
Time frame: Base and eighth week
Changes in Cancer-related fatigue level
Changes in Cancer-related fatigue level after eigth weeks treatment
Time frame: Base and eighth week
Changes in Physical Condition Score
Changes in Physical Condition Score after eight weeks treatment
Time frame: Base and eighth week
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