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Recruiting NCT06772935

Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electro-acupuncture.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Electro-acupuncture
    A method of acupuncture that combines acupuncture with a certain frequency of electrical stimulation. Electrical stimulation is a mild level of stimulation intensity that is acceptable to the human body.

Primary outcome measures

  • Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index (FACT/GOG-NTX) [Time frame: 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 outcome measures (1)
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20. [Time frame: 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).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qinghai University Affiliated Hospital — Xining

Identifiers

NCT: NCT06772935 · AHQU-2025001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗