True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatmentSham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment
True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment: Participants will receive a total of 8 treatments over 6 weeks, with twice a week treatments for the first and the forth weeks and weekly treatment for the remaining weeks.The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. In the meantime, participants will receive the same standard anti-CIPN treatments.
Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment: The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. In the meantime, participants will receive the same standard anti-CIPN treatments.
Study summary
This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 18 years of age or older, of any nationality.
* Patients diagnosed with malignant tumor.
* Eligible patients will report altered sensations and/or pain and/or other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).
* Predicted life expectancy of ≥3 months.
* Intact skin without any breaches or purulent discharge.
* Written informed consent by the patient before enrolment Patients must be able to comply with the study protocol, which includes attending the treatment sessions on time and completing the study questionnaires in accordance with the study protocol.
Exclusion Criteria:
* History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.
* Patients with skin damage, pus or scar at the acupuncture stimulation area.
* Patients who are pregnant or breastfeeding.
* Significant mental conditions.
* Patients not fulfilling the inclusion criteria.
* Patients receiving other acupuncture treatments during the trial.
Primary outcome measure(s)
Difference of the CIPN grade from baseline to week 6 after baseline — From enrollment to week 6 The primary outcome will be the proportion of patients whose CIPN grade improved after the completion of 8 acupuncture treatments sessions.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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