Chemotherapy-induced Peripheral Neuropathy. Drug-induced polyneuropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
China, Iran (Islamic Republic of)
Contacts
Beijing University of Chinese Medicine