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Clinical observation of electroacupuncture in the treatment of breast cancer related depression and its effect on fMRI brain function

Clinical observation of electroacupuncture in the treatment of breast cancer related depression and its effect on fMRI brain function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084143
Enrollment
Unknown
Registered
2024-05-11
Start date
2024-05-11
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer related depression

Interventions

Electroacupuncture group:electroacupuncture
sham-electroacupuncture group: sham-electroacupuncture
Breast cancer non depression group: none

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for depressed patients with breast cancer: (1) It meets the diagnostic criteria of breast cancer, and TNM stage is ?~?; Conforming to the diagnostic criteria of depression, depression occurs after the diagnosis of breast cancer and is related to cancer itself or cancer related treatment; (2) 18-75 years old, female; (3) The Eastern Oncology Collaborative Group (ECOG) physical condition score in the United States is = 2 points; (4) 8 points = HAMD-17 score = 24 points, belonging to patients with mild to moderate depression; (5) Maintaining a stable dose of antidepressants for more than 4 weeks before treatment, or not taking antidepressants; (5) Estimated survival time = 6 months; (6) Never received acupuncture and moxibustion treatment; (7) Right handedness; (8) No contraindications for MRI examination; (9) Breast cancer patients whose tumor condition is stable and in the adjuvant treatment period, endocrine treatment period or observation period have no special treatment plans such as surgery, radiotherapy and chemotherapy in the near future; (10) Voluntarily participate in the study and sign an informed consent form. Inclusion criteria for non depressed patients with breast cancer: (1) Age, dominant hand, education level and course of breast cancer were matched with CRD patients of breast cancer; (2) Emotionally positive, HAMD-17 score = 7 points; (3) No history of functional or organic diseases or head injuries; (4) No contraindications for MRI examination: No metal substances (metal dentures, heart stents, pacemakers, steel nails, steel plates, intrauterine devices, etc.) in the body, no claustrophobia; (5) Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for depressed patients with breast cancer: (1) Depression caused by cancer pain and a Numerical Rating Scale (NRS) = 4, or other physical illnesses; (2) The subject has a serious suicidal tendency, or a score of = 3 points in the third clause of HAMD-17; (3) Have a history of drug abuse or addiction; (4) Received other treatments related to depression (such as electroconvulsive therapy, cognitive-behavioral therapy, etc.) within 3 months prior to baseline visit; (5) Patients who have installed pacemakers; (6) Merge serious major diseases such as heart, liver, and kidney; (7) Planned pregnancy, pregnancy, or lactation period; (8) Mental and intellectual abnormalities, unable to understand the provisions of various scales and complete evaluations; (9) The acupuncture site may have ulcers, abscesses, skin infections, etc; Patients with metal allergies or severe fear of needles. (10) Participants in other clinical medical trials within the past two months. Exclusion criteria for non depressed patients with breast cancer: (1) Patients with claustrophobia; (2) Patients who have received acupuncture and moxibustion treatment in the past one month or are about to receive acupuncture and moxibustion treatment in the past two months; (3) Participate in other clinical trials in the past two months.

Design outcomes

Primary

MeasureTime frame
the change in HAMD-17;

Secondary

MeasureTime frame
the change in HAMD-17;Patient Health Questionnaire-9 (PHQ-9);Core Quality of Life Scale(QLQ-C30);Pittsburgh Sleep Quality Index Scale(PSQI);Montreal Cognitive Assessment (MOCA);fMRI;Medication usage;

Countries

China

Contacts

Public ContactYuelai Chen

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

chenyuelai@163.com+86 130 2019 3726

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026