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NCT Number: NCT06772935

Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+86-18919007744

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electro-acupuncture

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.

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  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).

    This scale is used to evaluate the impact of chemotherapy induced peripheral neuropathy (CIPN) on the quality of life of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital

CONTACT

[email protected]

+86-18729989935

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Qinghai University

Other

Registry information

Acronym: CIPN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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