Neuroprotective Effect of Neurotropin on Chronic OXA-induced Neurotoxicity in Stage II and Stage III CRC Patients

NCT ID: NCT07320950

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-22

Brief 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

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Neurotropin 4 tablets/day

All the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Group Type: EXPERIMENTAL

Neurotropin

Intervention Type: DRUG

Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.

Neurotropin 8 tablets/day

All the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Group Type: EXPERIMENTAL

Neurotropin

Intervention Type: DRUG

Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.

Placebo

All the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo

Interventions

Neurotropin

Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.

Intervention Type: DRUG

Placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 to 75 years old
• Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
• should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
• Agreed and assigned the consent, and was able to receive the baseline assessment
• Could be inpatient or outpatient participants

Exclusion Criteria

• Peripheral neuropathy patients, e.g. diabetes neuropathy
• Alcoholic related patients
• Central neuropathy patients
• Patients who were unable to assess the effectivity and safety
• Neurotropin allergy
• History of medications that are contraindicated to neurotropin <28 days before the trial begins
• Have already received neurotropin tablets more than 4 tablets or 3.6 units <4 weeks before the trials begins
• Unable to visit the hospital regularly
• Has been ruled out by investigators
• Brain tumor or metastasis
• Brain injury, stroke and brain hemorrhage symptoms occurred during 6 months after sign the consent
• History of epilepsy, convulsion
• Severe respiratory, cardiovascular, renal, hepatic or hematologic system(except cancer) disease
• Depression and other psychologic conditions which investigators recognized as high risk for the enrollment
• Chronic pain
• Received other medication from other clinical trials within 28 days
• Prepare for pregnancy, pregnant, or lactated women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Gong Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gong Chen, Prof

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Zhi-zhong Pan, Prof

Role: STUDY_CHAIR

Sun Yat-sen University

De-Sen Wan, Prof

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

B2020-061-01

Identifier Type: -

Identifier Source: org_study_id