Multicenter prospective registration and intervention studies for chemotherapy-induced peripheral neuropathy - MiroCIP Study

Kuwabara Satoshi0 个研究点目标入组 275 人开始时间: 2021年5月20日最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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

发起方

Kuwabara Satoshi