The objective of this study is to evaluate the efficacy and safety of CarebandR in breast cancer patients who completed chemotherapy, were diagnosed with peripheral neuropathy and require medication treatments for symptoms.
Peripheral neuropathy is reported in 19%~85% of cancer patients, and the major chemotherapy drugs are microtubule-targeting drugs including vinca alkaloids and taxane, epothilone and ixabepilone. As peripheral neuropathy impairs the quality of life and physical functionality in cancer patients, has been the major interest of not only patients but also health practitioners.
The hypothesis of this study is CarebandR, a wearable device with low frequency-stimulator, will improve the peripheral neuropathy in patients with breast cancer and prove safety.
To evaluate the efficacy and safety of CarebandR, we conduct a randomized, placebo-controlled, single-blind, explorative investigator initiated trial for subjects who require medication treatment including duloxetine or pregabalin.

Treatment

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, not distinguishable to the eye, is administered to the control group. Except medical device, other interventional condition is identical in two groups.
The subjects use the interventional medical device at least twice a day, in at least 120 minutes a day including consecutive 1 hour, for 14 days.

Arm Label

Target Number of Participant

Arm Type

Arm Description

CarebandR, a wearable device with low frequency-stimulator, is worn on the wrist of the subject. The subjects use the interventional medical device with the level 2 (100㎂, 40Hz) or more at least twice a day, in at least 120 minutes a day including consecutive 1 hour, for 14 days.

Arm Label

Target Number of Participant

Arm Type

Arm Description

A sham medical device, which does not generate electric stimulus and has identical appearance, not distinguishable to the eye, is administered to the control group. The sham medical device is worn on the wrist of the subject. The subjects use the interventional medical device at least twice a day, in at least 120 minutes a day including consecutive 1 hour, for 14 days.

Gender

Age

Description

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

Numerical rating scales (NRS)

Baseline (day 0) and 14 days after use of the device for clinical trial

TNS(Total Neuropathy Score)

Baseline (day 0) and 14 days after use of the device for clinical trial

the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale(EORTC QLQ-CIPN20)

Baseline (day 0) and 14 days after use of the device for clinical trial

The Instrument for Pattern Identification and Evaluation

Baseline (day 0) and 14 days after use of the device for clinical trial

The Functional Assessment of Cancer Therapy-Breast (FACT-B)

Baseline (day 0) and 14 days after use of the device for clinical trial