Clinical trial NCT06772935: Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer
Official title: Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
electroacupuncture
taxanes
SNPs
chemotherapy
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX）
timeFrame: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
Secondary outcomes:
measure: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20.
timeFrame: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References: