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Multicentre randomised controlled study of electroacupuncture combined with neoadjuvant chemotherapy for triple-negative breast cancer

Multicentre randomised controlled study of electroacupuncture combined with neoadjuvant chemotherapy for triple-negative breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086360
Enrollment
Unknown
Registered
2024-06-29
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative breast cancer

Interventions

Control group:Anthracycline combined with cyclophosphamide sequential paclitaxel neoadjuvant chemotherapy.
Electro-acupuncture group:During the first 2 cycles of neoadjuvant chemotherapy, electroacupuncture was given to the Zusanli and Fenglong points
30 min each time, 3 times a week.

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 to 75 years old; 2. Those with primary stage II-III triple-negative breast cancer diagnosed for the first time by pathology and immunohistochemistry; 3. Those who are going to receive anthracycline combined with cyclophosphamide sequential paclitaxel neoadjuvant chemotherapy regimen; 4. Who have at least one well-defined measurable tumor lesion according to RECIST 1.1 Criteria for Evaluation of Efficacy in Solid Tumours; 5. Who have an ECOG score of 0 to 1 6. Expected survival of 6 months or more; 7. Patients' informed consent and ability to cooperate with long-term follow-up.

Exclusion criteria

Exclusion criteria: 1. Those with a combination of other primary malignant tumors; 2. Patients with bilateral breast cancer; 3. Pregnant or breastfeeding women; 4. Those with serious heart, brain, liver, kidney, haematopoietic system and mental disorders or serious damage to organ function; 5. Having received any form of anti-tumour treatment (radiotherapy, chemotherapy and traditional Chinese medicine treatment, etc.) within one month; 6. Those who have received electro-acupuncture treatment within three months; 7. Those suffering from serious coagulation disorders or with potential bleeding tendency 8. Subjects with a history of alcoholism or drug dependence; 9. Those with pacemakers, metal allergies or severe needle fear; 10. Participants in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Clinilca benefit rate;Pathological complete remission rate;Miller-Payne grading system for breast cancer;Residual cancer burden;Peripheral blood lymphocyte levels;Proportion of lymphocytes infiltrating the mesenchymal fraction of the tumor area;EORTC Quality of Life Measurement Scale QLQ-C30 (V3.0);

Countries

China

Contacts

Public ContactSheng Liu

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

lshtcm@163.com+86 189 1776 3005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026