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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)

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)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0004217
Enrollment
90
Registered
2019-08-20
Start date
2018-11-08
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Electroacupuncture, Chuna manual therapy) : I. Control group: A group with repeated oral administration of one capsule of pregabalin (Product name, Lyrica capsule, 75mg) 30 minutes after meals

Sponsors

Catholic Kwandong University International St.Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
FACT/GOG-NTX;EORTC QLQ-CIPN 20;EORTC QLQ C30

Secondary

MeasureTime frame
Cancer treatment schedule completion rate;Nerve conducting study (NCS)

Countries

Korea, Republic of

Contacts

Public ContactTae-Yong Park

Catholic Kwandong University

parktae9822@gmail.com+82-32-290-3319

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026