Multicenter prospective registration and intervention studies for chemotherapy-induced peripheral neuropathy
- Conditions
- chemotherapy-induced peripheral neuropathy
- Registration Number
- JPRN-jRCTs031210101
- Lead Sponsor
- Kuwabara Satoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 275
Registry study
(1) Patients aged 20 years or older at informed consent
(2) The following cancer patients who are scheduled to have chemotherapy with Oxaliplatin or Taxane anticancer drugs within 14 days after the enrollment
-Colorectal cancer (scheduled to be treated according to regimens including Oxaliplatin)
-Gastric cancer (scheduled to be treated according to regimens including Oxaliplatin or Taxane anticancer drugs)
-Non-small cell lung cancer (scheduled to be treated according to regimens including Taxane anticancer drugs)
-Breast cancer (scheduled to be treated according to regimens including Taxane anticancer drugs)
(3) Patients who have voluntarily agreed in writing to participate in this study after receiving sufficient explanations from their study doctors and adequately understanding this study
Interventional study
(1) Patients aged 20 years or older at informed consent
(2) Colorectal, gastric, non-small cell lung, or breast cancer patients who are under chemotherapy treatment according to regimens including Oxaliplatin or Taxane anticancer drugs, and recognized to have chemotherapy-induced peripheral sensory neuropathy (CTCAE version 5.0 grade 2 or higher)
(3) Patients whose CIPN-induced pain (including tingling) NRS at enrollment is 4 or higher
(4) Patients who have voluntarily agreed in writing to participate in this study after receiving sufficient explanations from their study doctors and adequately understanding this study
Registry study
(1) Patients who have severe diabetes [HbA1c (NGSP) > 8.4%]
(2) Patients who have alcohol polydipsia history or alcoholism
(3) Patients who have severe cervical or lumbar spondylosis
(4) Patients with poor prognosis
(5) Patients whose CIPN-induced pains are difficult to be assessed due to the pains caused by the other diseases or factors
(6) Patients who are considered inappropriate for this study by Principal investigators or Sub investigators
Interventional study
(1) Patients whose CIPN-induced pains are difficult to be assessed due to the pains caused by the other diseases or factors
(2) Pregnant, possibly pregnant, or lactating patients
(3) Patients who have severe kidney, heart, or liver diseases
(4) Patients whose latest creatinine clearance (Cockcroft-Gault formula) is under 30 mL/min within 3 months before enrollment
(5) Patients with a history of hypersensitivity of Mirogabalin Besilate
(6) Patients with poor prognosis
(7) Patients whose receiving chemotherapy method is scheduled to be changed within 3 months after enrollment
(8) Patients who are scheduled to have surgery within 3 months after enrollment
(9) Patients who are considered inappropriate for this study by Principal investigators or Sub investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Registry study<br>Percentage of cases with peripheral sensory neuropathy (CTCAE version 5.0 grade 2 or higher) at 12 months after the chemotherapy start<br><br>Interventional study<br>Amount of change in the last 7-day pain (including tingling) NRS for 3 months after the administration start of Mirogabalin Besilate
- Secondary Outcome Measures
Name Time Method