Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

NCT ID: NCT06772935

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Electroacupuncture+Routine Nursing Group

Group Type: EXPERIMENTAL

Electro-acupuncture

Intervention Type: BEHAVIORAL

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.

Fake electroacupuncture + Routine Nursing Group

Group Type: PLACEBO_COMPARATOR

Electro-acupuncture

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role: lead

Responsible Party

Jiuda Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital

Role: CONTACT

zywm0001@163.com

+86-18729989935

Facility Contacts

Yi Zhao Chief Physician at the Breast Center of Qinghai University Aff

Role: primary

24738297@qq.com

+86-18919007744

Other Identifiers

AHQU-2025001

Identifier Type: -

Identifier Source: org_study_id