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Not yet recruiting NCT07183813

Acupuncture for Anxiety/Depression in Patients With Breast Cancer

No phase Interventional Anxiety Depression Breast Cancer Acupuncture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroacupuncture group, Sham electroacupuncture.
Who it may be relevant to
Registry conditions: Anxiety Depression, Breast Cancer, Acupuncture. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Acupuncture for Anxiety and/or Depression Among Patients With Breast Cancer

Overview

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

Interventions

  • Device 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 wee
  • Device 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

Primary outcome measures

  • The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS). [Time frame: week 8]
Secondary outcome measures (11)
  • The change from baseline in the total score of HADS. [Time frame: weeks 4, 12, 16 and 20]
  • The change from baseline in the score of HADS-A and HADS-D [Time frame: 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 [Time frame: weeks 4, 8, 12, 16 and 20]
  • Change from baseline in Hamilton Depression Scale-14 [Time frame: Week 4, 8 and 20]
  • Change from baseline in Hamilton Depression Scale-17 [Time frame: Week 4, 8 and 20]
  • The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) [Time frame: weeks 4,8 and 20]
  • The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF) [Time frame: weeks 4, 8 and 20]
  • The change from baseline in the brief fatigue inventory (BFI) [Time frame: weeks 4, 8 and 20]
  • The change from baseline in the Insomnia Severity Index (ISI) [Time frame: weeks 4, 8 and 20]
  • The proportion of responders per the Patient Global Index of Improvement (PGI-I) [Time frame: weeks 8 and 20]
  • Collection of cranial MRI images. [Time frame: baseline and week 8]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Beijing

Identifiers

NCT: NCT07183813 · 2025-075-KY-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗