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NCT Number: NCT07320950

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

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.

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Key information

Conditions

Colorectal Cancer Chemically-Induced Disorders Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurotoxicity Syndromes Poisoning Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurotropin

Drug

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

Placebo

Other

placebo

Primary outcomes

  1. The incidence of peripheral neurotoxicity among groups

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

    Oxaliplatin specific neurotoxicity grade classification and assessment. Incidence of Grade 3 or higher peripheral neuropathy at the end of adjuvant chemotherapy

Secondary outcomes

  1. The completion rate of oxaliplatin based chemotherapy

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

    Calculate the exact cycles that the participants completed

  2. Fine motor functions assessment

    Time frame: From completion of adjuvant chemotherapy, assessed at 2 years.

    Questionaire to assess whether the patient could complete the fine movement such as writing and zip up

  3. Time from total recovery from neurotoxicity after the chemotherapy

    Time frame: From completion of chemotherapy, up to 3 years.

    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.

  4. Disease-Free Survival (DFS) Rate at 3 Years

    Time frame: From randomization up to 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).

  5. Overall Survival (OS) Rate at 3 Years

    Time frame: From randomization up to 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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