Clinical study on concurrent use of Electroacupuncture or Chuna manual therapy with Pregabalin for Chemotherapy-induced peripheral neuropathy : safety and effectiveness(Open-labelled, Parallel, Randomized Controlled Trial, Assessor-blinded)
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004217
- Lead Sponsor
- Catholic Kwandong University International St.Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1. Adult men and women aged 18-85
2. Colorectal cancer patients with Oxaliplatin-induced peripheral neuropathy or breast cancer patients with Taxen-induced with peripheral neuropathy
(Provided that the patients have had peripheral neuropathy for 1 month or longer after the chemotherapy before the time of screening and have peripheral sensory/motor neuropathy of Grade 2 or higher based on Common Terminology Criteria for Adverse Events (CTCAE) V5.0 at the time of screening)
3. Those who do not have significant restrictions on their behavior and life, corresponding to ECOG 0-2
4. . Patients who can read the symptom questionnaire, comprehend and answer accordingly
5. Patients who have given their consent to the clinical protocol and follow-up and also have given their voluntary consent to the Institutional Review Board (IRB)-approved document
1. If the patient currently has neuropathy due to a cause other than CIPN
(Diabetes, peripheral vascular disease, alcohol-induced, drug-induced and other neurological disorders)
2. If the patient has a renal disease or has such a history and the responsible doctor deems that pregabalin prescription is unsuitable
3. If the patient has a condition that affects the progress of Korean medicine treatment (electroacupuncture, Chuna manual therapy) such as skin lesion or fracture lesion
4. If the patient has a fear or repulsion of Korean medicine treatment (electroacupuncture therapy, Chuna manual therapy)
5. If the patient received oriental medicine treatment such as acupuncture, moxibustion, cupping therapy and oriental medication related to chemotherapy-induced peripheral neuropathy within one week of the time of screening
6. If the patient has other illnesses or factors that may be regarded as not appropriate for the clinical study
7. If the responsible doctor has determined that the patient is not suitable to participate in this study
8. Women of childbearing age and pregnant or lactating women
9. Those who participated in other clinical studies within 30 days prior to the screening of this clinical study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FACT/GOG-NTX;EORTC QLQ-CIPN 20;EORTC QLQ C30
- Secondary Outcome Measures
Name Time Method Cancer treatment schedule completion rate;Nerve conducting study (NCS)