Combination of Acupuncture and 'Qizhu Fomula' Improves Relapse-free Survival in Patients with Triple-negative Breast Cancer: A Randomized, Controlled Study during the Perioperative Period

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053612

Enrollment

Unknown

Registered

2021-11-25

Start date

2022-01-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Malignant tumor of breast

Interventions

Treatment group:Qizhu formula + electroacupuncture

Control group:Placebo + sham acupuncture

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Female, aged 18 to 70 years; 2.Preoperative breast lump puncture pathology diagnosed as triple-negative breast cancer; 3.The breast specialist judges the person who plans to undergo breast cancer surgery; 4.Have not received any tumor related treatment, including surgery, chemoradiotherapy, endocrine therapy, immunotherapy, etc.; 5.Traditional Chinese medicine syndrome differentiation belongs to Qi deficiency and blood stasis type; 6.With the patient's informed consent.

Exclusion criteria

Exclusion criteria: 1.Unable to cooperate due to various reasons; 2.Patients with serious diseases of circulatory system, respiratory system, digestive system, blood system, urinary system, nervous system and endocrine system, and the researcher believes that the patients with serious diseases of other systems will affect the results of this study, or cannot be treated under general anesthesia; 3.Distant metastasis of breast cancer. 4.Known to have any other malignant tumour; 5.Concurrent participation of other clinical investigators; 6.Have a history of drug abuse; 7.Unable to use traditional Chinese medicine drugs due to allergy and other reasons; 8.Patients who cannot be punctured due to local skin infection at meridians; 9.Patients who took traditional Chinese medicine regularly and regularly in the past three months before the experiment (>= 5 days a week, intermittent <= 7 days); 10.Patients who had received electroacupuncture treatment before the experiment.

Design outcomes

Primary

Measure	Time frame
Relapse free survival;	—

Secondary

Measure	Time frame
Change rate of immune markers and immune gene expression value;Quality of life assessment;Safety index;	—

Countries

China

Contacts

Public ContactSheng Jiayu

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

sjy1983sh@126.com+86 13361990930

Outcome results

None listed

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