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A randomized controlled trial and clinical mechanism exploration of the acupuncture using tonifying heart and mind method intervention for triple-negative breast cancer chemotherapy-related cognitive impairment

A randomized controlled trial and clinical mechanism exploration of the acupuncture using tonifying heart and mind method intervention for triple-negative breast cancer chemotherapy-related cognitive impairment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080147
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-01-22
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Chemotherapy-related cognitive impairment

Interventions

acupucture group:acupuncture using reconciling qi and blood,tonifying heart and mind method
sham acupuncture group:the shallow acupuncture in non-acupoints and non-meridians

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients with histological, cytological, or radiographically confirmed triple-negative breast cancer.2.Age 18-65 years.3.Patients with cognitive impairment within 3 years after chemotherapy and have mild cognitive impairment.4.Syndrome differentiation of TCM belongs to QiXueShiTiao type.5.Expected survival of more than 1 year.6.Informed consent and voluntary signing of the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1.Suffering from mental disorders can interfere with cognitive function evaluation.2.Having alcohol dependence or abuse of other psychoactive substances; Taking medications that affect cognition in the last 3 months.3.Having severe visual acuity, hearing impairment, severe aphasia or dysgnosia.4.Having severe internal diseases or having central nervous system diseases,such as severe anemia, cacotrophy and so on.5.Those with brain metastases, encephalorrhagia,cerebral thrombosis,traumatic brain injury,or severe cardiovascular disease.6.Those who have received any cognitive rehabilitation within 3 months.7.Those who are unable to complete the relevant scale testing on their own for other causes.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment, MOCA;

Secondary

MeasureTime frame
Mini-mental State Examination,MMSE;EORTC QLQ-C30;cytokine(TNF-a,IL-1ß,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17,IFN-?,IFN-a);

Countries

China

Contacts

Public ContactGao Chong

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.

gaochong9356@126.com+86 188 1026 6211

Outcome results

None listed

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