NCT07320950CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 333 (actual)
- First submitted
- 4 Jan 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07320950
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 333
- From 1 Apr 2022 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Received other medication from other clinical trials within 28 days
Other illness
- Peripheral neuropathy patients, e.g. diabetes neuropathy
- Neurotropin allergy
- 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
Other
- Alcoholic related patients
- Central neuropathy patients
- Patients who were unable to assess the effectivity and safety
- Unable to visit the hospital regularly
- Has been ruled out by investigators
- Brain tumor or metastasis
- Chronic pain
- Prepare for pregnancy, pregnant, or lactated women
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.