Acupuncture for Anxiety/Depression in Patients With Breast Cancer

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Breast Cancer; Anxiety Depression; Acupuncture

Treatments: Device: Sham electroacupuncture; Device: Electroacupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT07183813

2025-075-KY-01

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 2 patient groups

Electroacupuncture group

Experimental group

Description:

Acupoints:Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu SanLi acupoint, Tai Chong acupoint, Shen Men acupoint.

Treatment:

Device: Electroacupuncture group

Sham electroacupuncture (SEA) group

Sham Comparator group

Description:

Acupoints: Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu San Li acupoint, Tai Chong acupoint, Shen Men acupoint.

Treatment:

Device: Sham electroacupuncture