NCT03048591UnknownNot Applicable
The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
Tianjin Medical University Cancer Institute and Hospital0 sites72 target enrollmentStarted: February 10, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 72
- Primary Endpoint
- Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
Study Overview
Brief Summary
Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
- •15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
- •zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.
- •Gender unrestricted, aged between 18 to 80 years old.
- •Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.
Exclusion Criteria
- •Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.
- •Patients who are being treated with other drugs that may lead to neurotoxicity .
- •Patients with blood coagulation disorder.
- •Pregnancy and lactating women.
- •Patients with infection, scarring or defects near the acupoint sites.
- •Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.
Arms & Interventions
Electroacupuncture group
Experimental
Intervention: electroacupuncture (Device)
control group
No Intervention
Outcomes
Primary Outcomes
Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
Time Frame: 6 weeks
Secondary Outcomes
- Functional Assessment of Cancer Treatment - General scale（FACT-G）(6 weeks)
Investigators
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