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Acupuncture in the treatment of cancer-related mild-moderate depression in patients with breast cancer: a pragmatic randomized controlled trial

Acupuncture in the treatment of cancer-related mild-moderate depression in patients with breast cancer: a pragmatic randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016546
Enrollment
Unknown
Registered
2018-06-07
Start date
2018-06-15
Completion date
Unknown
Last updated
2018-06-11

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

Conditions

cancer related depression

Interventions

real acupuncture:acupucnture
sham acupuncture:skin-touch needle
Healthy control:will not receive any intervention

Sponsors

Guangdong Provincal hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with primary breast malignancy diagnosed pathologically or cytologically; (2) Meet diagnostic criteria for depression disorders (Diagnostic criteria for mental disorders in the United States (DSM-IV)), and the HAMD-17 questionnaire> 7 points and = 24 points. Patients with 5 of the following 9 symptoms lasted for at least 2 weeks and excluded history of depression, suicide and mania, family history of psychosis and sedative-hypnotics, steroids, and contraceptives currently used to cause depressive symptoms. Drugs, etc., can basically establish the diagnosis. 9 symptoms include: depressed; lack of interest; weight loss or increase; insomnia or excessive sleep; irritation or slow movement; fatigue or loss of energy; self-evaluation is too low or have guilt; Difficulties in focusing attention; thoughts about wanting to die or commit suicide (previously no history of mental illness); (3) The original underlying disease (if any) has a stable condition, such as good control of blood sugar and blood pressure, and does not affect the treatment of breast cancer; (4) had undergone mastectomy or partial resection, no distant metastatic lesions were found; or only a single visceral metastatic lesion (except intracranial metastases) and no evidence of disease progression was found within the last 6 months; (5) The patient is allowed to incorporate other drugs (such as endocrine drugs, antihypertensive drugs, etc.) during treatment, but the protocol cannot be changed or adjusted during the 2 weeks before treatment and during treatment; (6) Aged 18 to 75 years old, who has full civil capacity, volunteers to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. At the same time, there are serious or poorly controlled medical conditions (such as systemic lupus erythematosus, cirrhosis, etc.), or serious tumor complications and complications (such as oppressive jaundice, ascites, portal hypertension, etc.), Or with intracranial metastases; 2. Have been diagnosed with depression or other mental illness, whether recovered or not; 3. For any reason, life expectancy is less than 1 year; 4. Pregnancy, lactation women; 5. are participating in other clinical trials; 6. Failure to attend the clinic on time, poor adherence or inability to adhere to the follow-up.

Design outcomes

Primary

MeasureTime frame
HAMD-17;Sleep monitoring;

Secondary

MeasureTime frame
PSQI;FACT-B;

Countries

China

Contacts

Public ContactWenbin Fu

Department of Acupuncture and Moxibusti second affiliated hospital of Guangzhou University of Chines Medicine

fuwenbin@139.com+86 13808888626

Outcome results

None listed

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