Assessment of Brain Cognitive Impairment in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTang-Du Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Premenopausal patients with stage I-II breast cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
DeviceNeuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: chemotherapy1 intervention
Group B: Endocrine therapy1 intervention
Group C: Healthy control1 intervention
Trial outcomes
Primary outcomes
1
Change of gray matter volume of whole brain
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Time frame
Baseline, 6,18,30 months later2
Change of white matter integrity of whole brain.
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Time frame
Baseline, 6,18,30 months later3
Change of metabolism of glucose in the brain
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography
Time frame
Baseline, 6,18,30 months later4
Change of functional connectivity of whole brain
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence
Time frame
Baseline, 6,18,30 months laterSecondary outcomes
1
Change of the concentration of serum biomarkers.
The concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL
Time frame
Baseline, 6,18,30 months laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tang-Du Hospital
Lead sponsor
Xi'an Jiaotong University
Collaborator
Source ClinicalTrials.gov