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

Phase 3CompletedNCT07320950

Sun Yat-sen University333 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

333

Conditions

Colorectal Cancer

Interventions

Neurotropin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

The completion rate of oxaliplatin based chemotherapy

Calculate the exact cycles that the participants completed

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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.