Assessment of Brain Cognitive Impairment in Breast Cancer
Recruiting · NCT05305092 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tang-Du Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
What this trial is 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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Tangdu Hospital - Xi'an, Shaanxi, China