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Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer (CIPN)

A

Affiliated Hospital of Qinghai University

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: Electro-acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06772935
AHQU-2025001

Details and patient eligibility

About

Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Full description

Chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. The latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. In addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. This study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening SNPs related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. Eligible patients diagnosed as stage I, II or IIIA breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (FACT/GOG-NTX) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN Twenty Item Scale (EORTC QLQ-CIPN20). All items in the above two scales are scored using Likert's 5 and 4 levels. The researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. Laboratory personnel are unaware of all clinical and outcome data.

Enrollment

162 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Breast cancer patients diagnosed by pathology;

    • EOOG score is 0 or 1;

      • The age range for enrollment is between 18 and 75 years old; ④ Accept chemotherapy regimens based on taxane drugs (alone or in combination);

        ⑤ Previously received taxane chemotherapy for more than 6 months;

        ⑥ According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0, reporting CIPN symptoms of grade 1 or higher for more than 2 weeks;

        ⑦ Voluntarily participate in this clinical trial and sign the informed consent form;

        • Accept regular follow-up visits; ⑨ There is complete pathological data available.

Exclusion criteria

  • Non breast cancer patients;

    • Received electroacupuncture treatment within 6 months prior to the start of the study;

      • Patients who experience intolerable toxic side effects during standard dose chemotherapy and terminate the chemotherapy cycle;

        • Prior to enrollment, there was a history of peripheral neuropathy;

          • Unstable heart disease or myocardial infarction within the first 6 months of the study;

            ⑥ Active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment;

            ⑦ Uncontrolled epilepsy patients with uncontrolled seizures;

            ⑧ Merge with other malignant tumor patients;

            ⑨ Pregnancy and lactation period;

            ⑩ Refusal to join clinical trial patients

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

162 participants in 2 patient groups, including a placebo group

Electroacupuncture+Routine Nursing Group
Experimental group
Treatment:
Behavioral: Electro-acupuncture
Fake electroacupuncture + Routine Nursing Group
Placebo Comparator group
Treatment:
Behavioral: Electro-acupuncture

Trial contacts and locations

1

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Central trial contact

Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital

Data sourced from clinicaltrials.gov

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