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Effectiveness of acupuncture in treatment of chemotherapy induced peripheral neuropathy

Not Applicable
Conditions
Chemotherapy-induced Peripheral Neuropathy.
Drug-induced polyneuropathy
G62.0
Registration Number
IRCT20190615043900N1
Lead Sponsor
Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Patients with age between 18 and 70 years
Who have received neurotoxic chemotherapy (at least one complete course)
Have experienced symptoms of chemotherapy-induced peripheral neuropathy for more than three months
Have scores = 4 on 10 on the Numerical Rating Scale (NRS)
Accept and sign an informed consent form
Patients were also not to use medications such as Tricyclic antidepressants (TCA), calcium channel blockers, and membrane stabilizing drugs for the prevention or treatment of the neuropathy for at least one month before enrollment

Exclusion Criteria

History of disease that causes neuropathy, such as diabetes, multiple sclerosis, HIV, and Parkinson
The presence of peripheral neuropathy or history of peripheral neuropathy due to any cause excluding chemotherapy
Alcohol abuse
Pregnancy
Psychological disease
Severe dysfunction of the heart, kidneys, or liver

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Chemotherapy induced peripheral neuropathy symptom severity. Timepoint: Befor treatment, 2 and 4 weeks after starting treatment, as well as 4 weeks after the end of treatment (after 8 weeks). Method of measurement: Chemotherapy induced peripheral neuropathy symptom severity will be assessed by asking patients to rate their average neuropathic symptoms, such as tingling, numbness and pain, on an 11-point scale (Numerical Rating Scale) over the course of a particular day.
Secondary Outcome Measures
NameTimeMethod
Grade of sensory neuropathy. Timepoint: Before treatment, 2 and 4 weeks after starting treatment, as well as 4 weeks after the end of treatment (after 8 weeks). Method of measurement: According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Severity of Neuropathy. Timepoint: Before and after treatment. Method of measurement: Nerve Conduction Study (NCS).;Patient Overall Satisfaction with Treatment. Timepoint: At the end of treatment and after 4 weeks follow-up (after 8 weeks). Method of measurement: Four-point Likert-type scale.;Safety Assessment. Timepoint: After each acupuncture session. Method of measurement: Signs and/or reports of excessive bruising, local persistent pain, and evidence of bleeding.;Adverse events. Timepoint: Any time in course of study. Method of measurement: Report by patients and researchers.
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