Acupuncture for Anxiety/Depression in Patients With Breast Cancer

NCT07183813 · tracked via the Priya Life Science China tracker

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Phase

Not applicable

Started

2025-09-15

Last updated

2025-09-24

Condition(s) studied

Anxiety DepressionBreast CancerAcupuncture

Investigational drug(s) / intervention(s)

Electroacupuncture groupSham electroacupuncture

Electroacupuncture group: The needles will be inserted to 15-40mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance. The electronic acupuncture apparatus will be connected to the bileteral Taiyang, Anmian and Baihui, with a continuous wave of 2 Hertz (Hz) and an electric current of 1-3 milliampere (mA). Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.

Sham electroacupuncture: The needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad till reaching but without penetrating the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral An Mian acupoints, with a continuous wave of 2 Hertz (Hz) and an electric current of 0.1-0.3 mA. In about 3-5 seconds, the electric current will be turned down. Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.

Study summary

The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Female, aged 18 to 70 years old; 2. Meeting the diagnostic criteria for breast cancer and at TMN I-III; 3. Having completed specialized active treatment for at least one month; 4. With an ECOG score of 0-2; 5. Mild to moderate anxiety and/or depression; 6. Voluntarily joining this study and signing the informed consent form. Exclusion Criteria: 1. Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment; 2. Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months; 3. With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer; 4. Patients with suicidal tendencies, bipolar disorder and psychotic symptoms; 5. Patients with severe anxiety and/or depression； 6. Patients received acupuncture treatment within one month before enrolment; 7. Participating in other clinical studies on the treatment of anxiety and/or depression; 8. Combined with severe underlying diseases; 9. Patients with severe skin ulcers; 10. Pregnant or lactating patients; 11. Poor compliance.

Primary outcome measure(s)

The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS). — week 8
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.

Trial sites (1)

Facility	City	Region	Status
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07183813 on ClinicalTrials.gov ↗ ← All trials in China