CompletedPhase 3

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

China333 participantsStarted 2022-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of peripheral neurotoxicity among groups

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

Trial details

NCT IDNCT07320950

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

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