Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurotropin 4 tablets/day | Experimental | All the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
|
| Neurotropin 8 tablets/day | Experimental | All the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
|
| Placebo | Placebo Comparator | All the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurotropin | Drug | Participants would be assess the safety and evaluate the neurotoxicity after the last cycle of whole chemotherapy regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the end of chemotherapy (up to 8 cycles, each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The completion rate of oxaliplatin based chemotherapy | Calculate the exact cycles that the participants completed | At the end of chemotherapy (up to 8 cycles, each cycle is 21 days) |
| Fine motor functions assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gong Chen, Prof | Sun Yat-sen University | Principal Investigator |
| Zhi-zhong Pan, Prof | Sun Yat-sen University | Study Chair |
| De-Sen Wan, Prof | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C010491 | neurotropin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | placebo |
|
Questionaire to assess whether the patient could complete the fine movement such as writing and zip up
| 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. | 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). | 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. | From randomization up to 3 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |