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Clinical study on chemotherapy cognitive impairment in breast cancer with Yin Xing Tong Zhi tables—an observational cohort trial

Clinical study on chemotherapy cognitive impairment in breast cancer with Ginkgolone—an observational cohort trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065694
Enrollment
Unknown
Registered
2022-11-11
Start date
2022-11-11
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Breast Cancer

Interventions

YXTZs exposure group:Yin Xing Tong Zhi tables 1# tid po. total 12weeks
nonexposed group:preoperative chemotherapy and/or radiotherapy, as well as postoperative biological agents after surgery, according to the National Comprehensive Cancer Network

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Breast cancer is clearly diagnosed by pathological examination, and the pathological stage is stage I~III; 2. Patients who receive anthraline sequential/combined purple shirt regimen (neoadjuvant) chemotherapy for the first time after surgery with standard regimen and dose, within 1 year from the time of initial chemotherapy; 3. No recurrence and metastasis and intracranial abnormalities; 4. General cognitive function is normal, daily living ability is basically normal, no hearing, vision, language and other functional disorders, Karl Fischer score = 60 points; 5. Female patients aged 18-65 (including 18 and 65 years old); Willingness to undergo treatment, observation and examinations.

Exclusion criteria

Exclusion criteria: 1. Patients with dementia (MES screening scale 50 points), depression (SDS screening scale score greater than 53 points) and other psychiatric symptoms after screening by doctors with neuropsychological professional qualifications; 2. Patients with an estimated survival time of < 6 months; 3. Patients with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, and hematopoietic systems; 4. Women who are nursing, pregnant or planning to become pregnant; 5. History of alcohol or drug dependence, taking related drugs that affect cognition; 6. Allergic constitution and allergic to a variety of drugs; 7. Subjects who are participating in clinical studies of other drugs.

Design outcomes

Secondary

MeasureTime frame
FACT-cog;TCM evaluation of breast cancer depressive symptoms;Karnofsky, KPS;

Primary

MeasureTime frame
Incidence of memory and executive impairment;Event correlation potential P300;

Countries

China

Contacts

Public ContactLiu Sheng

Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

lshtcm@163.com+86 18917763005

Outcome results

None listed

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