Colorectal Cancer
Conditions
Keywords
Adverse event, Oxaliplatin, Neurotoxicity, Neurotropin, Management
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.
Interventions
DRUGNeurotropin
Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen.
OTHERPlacebo
placebo
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of peripheral neurotoxicity among groups | 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
| Measure | Time frame | Description |
|---|---|---|
| The completion rate of oxaliplatin based chemotherapy | At the end of chemotherapy (up to 8 cycles, each cycle is 21 days) | Calculate the exact cycles that the participants completed |
| Fine motor functions assessment | 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 |
| Time from total recovery from neurotoxicity after the chemotherapy | 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. |
| Disease-Free Survival (DFS) Rate at 3 Years | 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). |
| Overall Survival (OS) Rate at 3 Years | 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. |
Countries
China
Outcome results
None listed