Clinical trial NCT06994351: Acupuncture for Anxiety and Depression
Official title: The Effects of Acupuncture on Anxiety and Depression of Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety and Depression
Breast Cancer Survivor
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.


Eligibility criteria: 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 depression; (8) Combined with severe underlying diseases; (9) Patients with severe skin ulcers; (10) Pregnant or lactating patients; (11) Poor compliance.

Primary outcomes:
measure: The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 8
Secondary outcomes:
measure: The change from baseline in the HADS
timeFrame: weeks 4, 12, 16 and 20
measure: The change from baseline in the HADS-A and HADS-D
timeFrame: weeks 4, 8, 12, 16 and 20
measure: 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
timeFrame: weeks 4, 8, 12, 16 and 20
measure: The change from baseline in the Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: weeks 4, 8, 12, 16 and 20
measure: The change from baseline in the Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: weeks 4, 8, 12, 16 and 20
measure: Change from baseline in Hamilton Depression Scale-14
timeFrame: Week 4, 8, 12, 16, 20
measure: Change from baseline in Hamilton Depression Scale-17
timeFrame: Week 4, 8, 12, 16, 20
measure: The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer(FACT-B)
timeFrame: weeks 4,8, 12 and 20
measure: The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)
timeFrame: weeks 4, 8, 12 and 20
measure: The change from baseline in the brief fatigue inventory (BFI)
timeFrame: weeks 4, 8, 12, and 20
measure: The change from baseline in the Insomnia Severity Index (ISI)
timeFrame: weeks 4, 8, 12 and 20
measure: The proportion of responders per the Patient Global Index of Improvement (PGI-I)
timeFrame: weeks 8 and 20
Other outcomes:
measure: Expectance assessment
timeFrame: baseline
measure: Assessment of belief in acupuncture
timeFrame: baseline and week 8
measure: Blinding assessment
timeFrame: week 8
measure: Adherence assessment
timeFrame: through study completion, an average of five months
measure: Proportion of participants using rescue medicine.
timeFrame: through study completion, an average of five months
measure: Safety assessment
timeFrame: through study completion, an average of five months
Locations:
city: Beijing
country: China
facility: China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Yuanjie Sun
role: PRINCIPAL_INVESTIGATOR
References: