Status:
RECRUITING
Assessment of Brain Cognitive Impairment in Breast Cancer
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
Xi'an Jiaotong University
Conditions:
Breast Cancer
Chemo-brain
Eligibility:
FEMALE
Brief Summary
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairmen...
Detailed Description
Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. T...
Eligibility Criteria
Inclusion
- Patients with primary stage I-II breast cancer.
- Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
- No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
- Eastern Cooperative Oncology Group score of 0-1 points.
- Can understand and complete various scales.
- Right handedness.
- Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
- Sign the informed consent and voluntarily participate in this clinical observation.
Exclusion
- Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
- Current or former epilepsy, dementia, or learning disabilities.
- Past psychiatric history.
- Past history of malignancy.
- MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
Key Trial Info
Start Date :
May 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05305092
Start Date
May 31 2022
End Date
May 30 2027
Last Update
July 13 2022
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038