Neuroprotective Effect of Neurotropin on Chronic OXA-induced Neurotoxicity in Stage II and Stage III CRC Patients
NCT07320950 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333
Last updated 2026-01-06
Summary
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.
Conditions
Interventions
- DRUG
-
Neurotropin
Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.
- OTHER
-
Placebo
placebo
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Gong Chen, Prof · Sun Yat-sen University
-
Zhi-zhong Pan, Prof · Sun Yat-sen University
-
De-Sen Wan, Prof · Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2025-08-30
- Completion
- 2025-12-22
Countries
- China
Study Locations
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