RecruitingNot ApplicableNCT06858709

Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy

Effect of Adding Electroacupuncture Combined With Standard Anti Chemotherapy-induced Peripheral Neuropathy Drugs to Anti-cancer Therapy-induced Peripheral Neuropathy: a Randomized Multicentered Clinical Trial.


Sponsor

Zhongnan Hospital

Enrollment

150 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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.
  • Patients receiving other acupuncture treatments during the trial.

Exclusion Criteria4

  • 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.

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Interventions

PROCEDURETrue 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.

PROCEDURESham 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.


Locations(1)

Zhongnan hospital of Wuhan University

Wuhan, Hubei, China

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NCT06858709


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