Electroacupuncture for Chemotherapy-induced Peripheral Neuropathy

Electroacupuncture for Painful Chemotherapy-induced Peripheral Neuropathy: A Multicenter Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000789

Enrollment

146

Registered

2013-07-12

Start date

2013-07-22

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : A study that compares treatment efficacy of electroacupuncture plus medication VS medication alone in the treatment of chemotherapy-induced peripheral neuropathy. Electroacupuncture

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females aged 20 years and older 2. Patients who had received neurotoxic chemotherapy with a diagnosis of cancer 3. Symptoms of painful peripheral neuropathy of duration (= 1 month and =5 years) attributed to chemotherapy with taxane or platinum agents, and a score = 4 out of 10 on the NRS scale. 4. No use of medications to prevent or treat neuropathy within 2 weeks before screening. 5. ECOG PS of 0-2 6. Life expectancy = 6 months 7. Agreed with written informed consent

Exclusion criteria

Exclusion criteria: 1. Pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, peripheral vascular disease, HIV, alcohol, toxin, hereditary, nerve compression injuries, etc.) 2.Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure 3. A subject with history of allergies to study drug (gabapentin) or with rare hereditary problems of galactose intolerance, or glucose-galactose malabsorption 4. Received acupuncture, moxibustion, cupping or herbal medicine for peripheral neuropathy last 4 weeks 5. Cardiovascular disorder (e.g. arrhythmia) or using pacemaker 6. BUN, creatinine > 1.5 UNL 7. Pregnant, expecting pregnant or nursing women 8. Those who are not willing to comply with this study protocol

Design outcomes

Primary

Measure	Time frame
NRS (numerical rating scale)	—

Secondary

Measure	Time frame
BPI-SF (brief pain inventory-short form);Semmes Weinstein monofilaments test ;POMS-B (profile of mood states-brief);BFI (brief fatigue inventory);EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire);EQ-5D (EuroQol-5D);Patient Global Impression of Change (PGIC) ;Compliance ;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactJoo-Hee Kim

Korea Institute of Oriental Medicine

Outcome results