Effects and safety of mirogabalin therapy for paclitaxel-induced peripheralneuropathy

未提供0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月2日

试验速览

暂无简介。

•(1) Patients aged between 18 and 75 at the time o f consent
•(2) Patients with stage 1- 3C primary breast cancer
•(3) Patients with Grade 2 or higher peripheral neuropathy induced paclitaxel based on the NCI C ommon Toxicity Criteria for Adverse Events (CTCAE) ver 5.0 grading scale during or after receiving p aclitaxel in perioperative chemotherapy for primar y breast cancer
•(4) Eastern Cooperative Oncology Group Performa nce status 0 or 1
•(5) Patients who have agreed in writing to particip ate in this study after understanding this study an d who can adequately answer patient questionnaires.

•(1) Patients with peripheral neuropathy in the upp er or lower limbs at the time of perioperative chem otherapy
•(2) Patients who recieved other chemotherapy whi ch induce CIPN
•(3) Patients with injury or inflammatory diseases o n the skin of the forearms or lower legs
•(4) Patients with artificial cardiac pacemaker or ot her electronic implant
•(5) Patients whose estimated glemerular filtration r ate is under 60 mL/min/1.73 square metre
•(6) Patients whose AST or ALT is over 100 U/L
•(7) Patients who recieving pregabalin, provenesid, cimetidine and lorazepam
•(8) Patients with a history of hypersensitivity to mir ogabalin and similar material of mirogabalin
•(9) Patients with uncontrolled diabetes
•(10) Other patients that the research doctor deem s inappropriate

Amount of the change of peripheral neuropathy intensity

时间窗: from the enrollment to the end of the study

Visual Analogue Scale

Patient Neurotoxicity Questionnaire of the upper and lower limbs(from the enrollment to the end of the study)
FACT/COG-NTX(from the enrollment to the end of the study)
PainVision score of the upper and lower limbs(from the enrollment to the end of the study)
manipulation time of O'Connor Finger Dexterity Test(from the enrollment to the end of the study)
Subjective symptoms, somnolence, nausea, dizziness and peripheral edema
Adverse events of CTCAE ver 5.0 grading scale

发起方

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