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Assessment of Brain Cognitive Impairment in Breast Cancer

Assessment of Brain Cognitive Impairment in Breast Cancer

Recruiting
Female
Phase N/A

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Overview

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 impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.

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. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study details
    Breast Cancer
    Chemo-brain
    Endocrine Therapy

NCT05305092

Tang-Du Hospital

28 January 2024

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