A Randomized, Single-blind, Placebo-controlled, Single center, Investigator Initiated Trial to Evaluate the Efficacy and Safety of CarebandR for Chemotherapy Induced Peripheral Neuropathy Subjects

Chungnam National University Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1) Female aged 19 and over
•2) Persons who have experienced peripheral neuralgia of average NRS 5 or more in last 7 days after completing chemotherapy for breast cancer, and are diagnosed with peripheral neuropathy
•3) Persons with life expectancy of 12 months or more and the Eastern Cooperative Oncology Group Performance Status of 2 or less
•4) Persons who required medication treatment (Duloxetine or Pregabalin) with stable dosage and usage for clinical trial period (14 days) when observed from a week before clinical trial participation
•5) Persons who voluntarily agree to participate in the study in writing.

•1) Persons with severe peripheral neuropathy requiring surgery or acute treatment, or induced by injury and intercurrent disease
•2) Persons with dermatitis on the skin area where the device will be placed
•3) Persons who are not low-frequency stimulator naive including CarebandR
•4) Persons with pacemaker
•5) Persons experiencing hypersensitivity or allergy of medications or metal
•6) Persons with uncontrolled hypertension (systolic blood pressure of 170mmHg or more, or diastolic blood pressure of 100mmHg or more) or or uncontrolled diabetes
•7) Persons with severe hepatic failure or liver function disorder (ALT, AST, creatinine level of 3 times the upper limit of normal) at each blood test time
•8) Pregnant women, lactating women or persons who do not plan to contraceptive method (barrier method of birth control: surgical sterilization male condom, intrauterine device, and spermicides) except oral contraceptive pills
•9) Persons with medical history of psychiatric disorder or required to take antipsychotic medications
•10) Persons who were on drug for other clinical trials in 4 weeks before using the device for this clinical trial
•11) Persons who are judged unable to respond to a self reporting questionnaire due to lack of ability to read, understand and write words and letters
•12) Persons who are judged improper to participate in the study according to the decision of investigator

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