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

NCT07320950 | Completed Phase 3 DMC

• 1 other identifier: B2020-061-01
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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

Keywords

Adverse event; Oxaliplatin; Neurotoxicity; Neurotropin; Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The completion rate of oxaliplatin based chemotherapy

  At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)

• Fine motor functions assessment

  From completion of adjuvant chemotherapy, assessed at 2 years.

• Time from total recovery from neurotoxicity after the chemotherapy

  From completion of chemotherapy, up to 3 years.

• Disease-Free Survival (DFS) Rate at 3 Years

  From randomization up to 3 years

• Overall Survival (OS) Rate at 3 Years

  From randomization up to 3 years

Study Arms (3)

Neurotropin 4 tablets/day

EXPERIMENTAL

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

Neurotropin 8 tablets/day

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Neurotropin DRUG

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

Neurotropin 4 tablets/day; Neurotropin 8 tablets/day

Placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neurotoxicity Syndromes

Interventions

neurotropin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Gong Chen, Prof

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Zhi-zhong Pan, Prof

  Sun Yat-sen University

  STUDY CHAIR

• De-Sen Wan, Prof

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 6, 2026
• Study Start: April 1, 2022
• Primary Completion: August 30, 2025
• Study Completion: December 22, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)