An interventional study of Electro-acupuncture in Breast Cancer, sponsored by Affiliated Hospital of Qinghai University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Affiliated Hospital of Qinghai University · Not applicable, Interventional, and Treatment
Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 162 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Affiliated Hospital of Qinghai University is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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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 () 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 form;
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Electro-acupuncture
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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX）
This scale is mainly used to evaluate chemotherapy induced peripheral neuropathy (CIPN), especially the neurotoxic reactions in gynecological tumor treatment. Through this scale, it is possible to quantify the neurotoxic symptoms that patients experience after receiving chemotherapy, such as sensory abnormalities, motor dysfunction, etc., in order to better monitor and manage the patient's health status.
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).
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20.
This scale is used to evaluate the impact of chemotherapy induced peripheral neuropathy (CIPN) on the quality of life of patients.
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).
Plan to share: Undecided
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Affiliated Hospital of Qinghai University