Acupuncture for Anxiety/Depression in Patients With Breast Cancer
NCT ID: NCT07183813
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2025-09-15
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Electroacupuncture group
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.
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 (SEA) group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
Yes
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yuanjie Sun
Attending physician
Locations
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-075-KY-01
Identifier Type: -
Identifier Source: org_study_id
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