Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

NCT06772935 | Recruiting

• 1 other identifier: AHQU-2025001
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Conditions

Breast Cancer

Keywords

breast cancer; electroacupuncture; taxanes; SNPs; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20.

  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).

Study Arms (2)

Electroacupuncture+Routine Nursing Group

EXPERIMENTAL

Behavioral: Electro-acupuncture

Fake electroacupuncture + Routine Nursing Group

PLACEBO COMPARATOR

Behavioral: Electro-acupuncture

Interventions

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.

Electroacupuncture+Routine Nursing Group; Fake electroacupuncture + Routine Nursing Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female patients diagnosed with breast cancer. Male patients with breast cancer were excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital

CONTACT

+86-18729989935; zywm0001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In this study, subjects and evaluators were separated, and statistical analysis was conducted by a dedicated person who was responsible for the non-contact experimental operation process. However, due to the particularity of acupuncture and moxibustion clinical trials, acupuncture and moxibustion specialists are not blinded in the study. And the subjects, researchers, and clinical doctors are unaware of the allocation of research; Only electroacupuncture technicians and research statistics specialists know about the random allocation situation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

CN (1)