chemotherapy-induced peripheral neuropathy CIPN
Conditions
Interventions
Oral ingestion of test tablets with L.E.M. or placebo (12 grains per a day
Sponsors
Kawakami Hisato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with residual peripheral neuropathy for 3 months after oxaliplatin completion 2. It is diagnosed as adenocarcinoma (including mucinous cancer, signet ring cell carcinoma, and medullary carcinoma) in the 8th edition of the Colorectal Cancer Handling Regulations by histopathological diagnosis.. 3. The main occupied site by surgical and excised specimens is diagnosed from the cecum to the lower rectum (C, A, T, D, S, RS, Ra, Rb, P) in the 8th edition of the Colorectal Cancer Handling Regulations. 4. At the time of completion of surgery, residual cancer is considered to be R0 or R1. 5. No synchronous colorectal cancer 6. Patients diagnosed with Grade 1 or higher sensory CIPN based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0 grading scale 7. At the time of enrollment, patients with more than 40mm of the numbness VAS due to oxaliplatin-induced peripheral neuropathy. 8. 20 years old or older 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 10. Vital organ functions are preserved 11. Possible to take foods and drugs orally 12. Patients who can write with their dominant hand. Writing by a substitute is not allowed. Written informed consent from patient. 13. Patient has been informed of the study and agrees to its provisions and has provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with peripheral neuropathy other than CIPN, such as fibromyalgia and diabetic peripheral neuropathy. 2. Cases in which the drug dose to CIPN that has already been performed within 2 weeks before randomization is not stable*. *Patients who have an increase or decrease of 10% or more of the daily dose of the drug used. 3. Patients with serious complications (ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes, heart failure, renal failure, liver failure, etc.) 4. Patients with a severe complication Patients who have allergy to L.E.M. or similar chemical agents 5. Patients receiving gabapentin 6. Pregnant or lactating women and those who may or will become pregnant 7. Patients who participate in other clinical trials 8. Patient who is judged inappropriate to participate in this study by the principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the change in CIPN VAS (numbness) from start to the end of the initial treatment period (weeks 0-12) in the placebo and low-dose groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the change in CIPN VAS (pain) from start to the end of the initial treatment period (weeks 0-12) in the placebo and low-dose groups 2. Evaluate the change in CIPN VAS (numbness, pain) from start to the end of the initial treatment period (weeks 0-12) in the placebo and high-dose groups. 3. Evaluate the change in CIPN VAS (numbness, pain) from start to 4 and 8 weeks. 4. Peripheral sensory neuropathy grade(CTCAE Ver.4) every 4 weeks from the start of administration. 5. QOL survey using FACT-GOG / NTX every 4 weeks from the start of administration 6. Score of adverse events(CTCAE Ver.4) 7. Statistically estimate the dose-response relationship by sigmoid function, linear regression, etc. | — |
Contacts
Public ContactHisato Kawakami
Kindai University Hospital
Outcome results
None listed