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

Neuroprotective Effect of Neurotropin on Chronic Oxaliplatin-induced Neurotoxicity in Stage II and Stage III Colorectal Cancer Patients: a Randomized, Double-blind, Placebo-controlled, Parallel Grouping Multi-center Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Placebo; Drug: Neurotropin

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Neurotropin; Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.
Experimental: 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.	Drug: Neurotropin; Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.
Placebo Comparator: 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.	Other: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of peripheral neurotoxicity among groups	Oxaliplatin specific neurotoxicity grade classification and assessment. Incidence of Grade 3 or higher peripheral neuropathy at the end of adjuvant chemotherapy	At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completion rate of oxaliplatin based chemotherapy	Calculate the exact cycles that the participants completed	At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Fine motor functions assessment	Questionaire to assess whether the patient could complete the fine movement such as writing and zip up	From completion of adjuvant chemotherapy, assessed at 2 years.
Time from total recovery from neurotoxicity after the chemotherapy	The time (in months) from the first documented complete resolution of chemotherapy-induced peripheral neuropathy. Participants without recurrence will be censored at the date of last follow-up within the 3-year study period.	From completion of chemotherapy, up to 3 years.
Disease-Free Survival (DFS) Rate at 3 Years	The proportion of participants who are alive and free of disease (i.e., have not experienced disease recurrence or a new primary cancer) at 3 years from the date of randomization (or start of treatment).	From randomization up to 3 years
Overall Survival (OS) Rate at 3 Years	OS is defined as the time from the date of randomization to the date of death from any cause. Participants who are still alive at the time of analysis will be censored at the last known alive date.	From randomization up to 3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Gong Chen, Prof, Sun Yat-sen University; Study Chair: Zhi-zhong Pan, Prof, Sun Yat-sen University; Study Director: De-Sen Wan, Prof, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): December 22, 2025

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Management; Adverse event; Oxaliplatin; Neurotoxicity; Neurotropin
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Chemically-Induced Disorders; Poisoning; Colorectal Neoplasms; Neurotoxicity Syndromes; neurotropin
• Other Study ID Numbers: B2020-061-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No