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Completed

NCT Number: NCT01526564

Clinical Study on Acetyl-L-Carnitine

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.

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Key information

Age range

18 week–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetylcarnitine

Drug

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

Other names: NICETILE

Placebo

Drug

3 t.i.d, two plates per time

Primary outcomes

  1. Changes in peripheral sensory neuropathy grades

    Time frame: Base and eighth week

    Changes in peripheral sensory neuropathy grades after eight weeks treatment

Secondary outcomes

  1. Changes in Neuroelectrophysiological test

    Time frame: Base and eighth week

    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment

  2. Changes in Cancer-related fatigue level

    Time frame: Base and eighth week

    Changes in Cancer-related fatigue level after eigth weeks treatment

  3. Changes in Physical Condition Score

    Time frame: Base and eighth week

    Changes in Physical Condition Score after eight weeks treatment

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Collaborators

  • Shanghai Changzheng Hospital
  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 6, 2012
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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