Assessment of Brain Cognitive Impairment in Breast Cancer

Tang-Du Hospital

Status: Enrolling

Conditions: Breast Cancer; Endocrine Therapy; Chemo-brain

Treatments: Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample

Study type: Observational

Funder types: Other

Identifiers

NCT05305092

82071993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

chemotherapy

Description:

Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery

Treatment:

Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample

Endocrine therapy

Description:

Premenopausal breast cancer patients receiving endocrine therapy alone after surgery

Treatment:

Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample

Healthy control

Description:

Healthy non-cancer controls

Treatment:

Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample