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Acupuncture treatment of breast cancer after chemotherapy in patients with cognitive impairment caused by 'disorder of qi and blood': a randomized single-blind study

Randomized, single-blind, sham acupuncture-controlled trial of acupuncture treatment of breast cancer after chemotherapy in patients with cognitive impairment caused by 'disorder of qi and blood'

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12049699
Enrollment
100
Registered
2015-03-25
Start date
2014-10-01
Completion date
Unknown
Last updated
2015-07-06

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

Conditions

Breast cancer after chemotherapy in patients with cognitive impairment Cancer

Interventions

The 100 eligible participants are randomly allocated to two different groups: 1. Treatment group: acupuncture will be given at Zusanli (ST 36) Point?Xuhai Point?Tanzhong Point?Zhongwan Point?Qihai (

Sponsors

Beijing Hospital of Traditional Chinese Medicine (TCM)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer at the age of 25 to 55 years old 2. Neuropsychological evidence of cognitive impairment 3. In the 28 months after chemotherapy according to DSM-IV diagnosis of cognitive impairment 4. According to the MoCA score < 26 points, determining with cognitive dysfunction 5. There is a causal relationship between chemotherapy and cognitive impairment, and except for other diseases 6. The type of traditional Chinese medicine is a disorder of qi and blood 7. At least one field of cognitive dysfunction 8. Diagnosis of dementia standard has not yet arrived 9. Have signed informed consent

Exclusion criteria

Exclusion criteria: 1. Because of the depression, thyroid disease, traumatic brain injuries, drug or alcohol poisoning cause cognitive impairment 2. Patients with severe aphasia, depression and mental illness 3. Patients with severe heart, liver, lung, kidney damage caused by cognitive decline and hematopoietic system, endocrine system, severe primary disease 4. Patients can affect the cognitive function of drugs

Design outcomes

Primary

MeasureTime frame
Using the Montreal Cognitive Assessment (MoCA)to assess cognitive function. To observe the cognitive ability of patients with breast cancer after chemotherapy with cognitive dysfunction. The outcome measure above will be assessed before the treatment, at 1 month and 2 months during the treatment; the assessments will be repeated at the second and fourth months after the treatment.

Secondary

MeasureTime frame
1. Using the Mini-mental State Examination to assess immediate memory, attention, computing power, etc. 2. Using the EORTC QLQ-30 to assess the quality of life. The outcome measures above will be assessed before the treatment, at 1 month and 2 months during the treatment; the assessments will be repeated at the second and fourth months after the treatment. 3. Safety assessment. Acupuncture treatment can lead to curved needle, needle breakage and adverse reactions such as subcutaneous hematoma, therefore we will evaluate the safety of acupuncture.

Countries

China

Outcome results

None listed

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