Clinical trial · Interventional
Clinical Study on Acetyl-L-Carnitine
Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce
NCT01526564CI-TRIAL-00012618completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Sensory Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetylcarnitine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ALC
- description
- ALC
- interventionNames
- Drug: Acetylcarnitine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Changes in peripheral sensory neuropathy grades
- timeFrame
- Base and eighth week
- description
- Changes in peripheral sensory neuropathy grades after eight weeks treatment
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Weeks
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.