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| Name | Class |
|---|---|
| Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Changzheng Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALC | Active Comparator | ALC |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in peripheral sensory neuropathy grades | Changes in peripheral sensory neuropathy grades after eight weeks treatment | Base and eighth week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000108 | Acetylcarnitine |
| ID | Term |
|---|---|
| D002331 | Carnitine |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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|
| Placebo | Drug | 3 t.i.d, two plates per time |
|
| Base and eighth week |
| Changes in Physical Condition Score | Changes in Physical Condition Score after eight weeks treatment | Base and eighth week |
| D009930 |
| Organic Chemicals |