Acupuncture for Anxiety/Depression in Patients With Breast Cancer

NCT07183813 | Not Yet Recruiting

• 1 other identifier: 2025-075-KY-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Depression; Breast Cancer; Acupuncture

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).

  The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.

  week 8

Secondary Outcomes (11)

• The change from baseline in the total score of HADS.

  weeks 4, 12, 16 and 20

• The change from baseline in the score of HADS-A and HADS-D

  weeks 4, 8, 12, 16 and 20

• Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7

  weeks 4, 8, 12, 16 and 20

• Change from baseline in Hamilton Depression Scale-14

  Week 4, 8 and 20

• Change from baseline in Hamilton Depression Scale-17

  Week 4, 8 and 20

Other Outcomes (6)

• Expectance assessment

  baseline

• Assessment of belief in acupuncture

  baseline and week 8

• Blinding assessment

  week 8

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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.

Device: Electroacupuncture group

Sham electroacupuncture (SEA) group

SHAM COMPARATOR

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.

Device: Sham electroacupuncture

Interventions

Electroacupuncture group DEVICE

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.

Electroacupuncture group

Sham electroacupuncture DEVICE

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.

Sham electroacupuncture (SEA) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18 to 70 years old;
• Meeting the diagnostic criteria for breast cancer and at TMN I-III;
• Having completed specialized active treatment for at least one month;
• With an ECOG score of 0-2;
• Mild to moderate anxiety and/or depression;
• Voluntarily joining this study and signing the informed consent form.

You may not qualify if:

• Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment;
• Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months;
• With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer;
• Patients with suicidal tendencies, bipolar disorder and psychotic symptoms;
• Patients with severe anxiety and/or depression；
• Patients received acupuncture treatment within one month before enrolment;
• Participating in other clinical studies on the treatment of anxiety and/or depression;
• Combined with severe underlying diseases;
• Patients with severe skin ulcers;
• Pregnant or lactating patients;
• Poor compliance.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yuanjie Sun

CONTACT

+8618810337542; puzhisun@163.com

Shuai Gao

CONTACT

+8613128205732; gaoshuai980314@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until until six months after publication.
• Access Criteria: Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.

Locations

CN (1)