None listed
Conditions
Interventions
Medical Device : A low frequency-stimulator, CarebandR, is administered to the intervention group, whereas sham medical device, which does not generate electric stimulus and has identical appearance,
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical rating scales (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| TNS(Total Neuropathy Score);the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale(EORTC QLQ-CIPN20);The Instrument for Pattern Identification and Evaluation;The Functional Assessment of Cancer Therapy-Breast (FACT-B) | — |
Countries
Korea, Republic of
Contacts
Public ContactHwa-Seung Yoo
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed