Acupuncture for Anxiety/Depression in Patients With Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Anxiety Depression; Breast Cancer; Acupuncture

• Registration Number: NCT07183813
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-14
• Study First Submitted QC: 2025-09-14
• Study Start: 2025-09-15
• Study First Posted: 2025-09-19
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The change from baseline in the total score of HADS.	weeks 4, 12, 16 and 20	The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the score of HADS-A and HADS-D	weeks 4, 8, 12, 16 and 20	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
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	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Change from baseline in Hamilton Depression Scale-14	Week 4, 8 and 20	The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1959 and is a clinical tool used to assess anxiety symptoms. All items use a 5-point rating scale from 0 to 4, with a total score ranging from 0 to 56. The cut-off value is 14 points. Generally, a score of \>14 points indicates anxiety, \>29 points indicates severe anxiety, and the higher the score, the more severe the anxiety symptoms.
Change from baseline in Hamilton Depression Scale-17	Week 4, 8 and 20	The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1960 and is the most commonly used scale in clinical assessment of depressive states. All items are scored on a 5-point scale ranging from 0 to 4. The total score is 68. A score of 8-17 indicates mild depression, 18-24 indicates moderate depression, and a score of ≥25 indicates severe depression.
The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)	weeks 4,8 and 20	The FACT-B is a specific scale designed to measure the quality of life in breast cancer patients. The total score of the questionnaire range from 0 to 144, with higher scores indicating worse quality of life.
The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)	weeks 4, 8 and 20	The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients.
The change from baseline in the brief fatigue inventory (BFI)	weeks 4, 8 and 20	The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue.
The change from baseline in the Insomnia Severity Index (ISI)	weeks 4, 8 and 20	The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity.
The proportion of responders per the Patient Global Index of Improvement (PGI-I)	weeks 8 and 20	The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse". The score of the scale ranges from 1 to 7.
Collection of cranial MRI images.	baseline and week 8	Data were acquired at the Department of Radiology using a Magneton Skyra 3.0 T MR scanner.

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China