Clinical trial NCT05305092: Assessment of Brain Cognitive Impairment in Breast Cancer
Official title: Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Chemo-brain
Endocrine Therapy
Keywords: CRCI
psycho-behavioral technology
Integrated PET/MRI technology
Biomarkers
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
First posted: 2022-03-31
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premenopausal patients with stage I-II breast cancer.

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

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. 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 criteria: 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.

Primary outcomes:
measure: Change of gray matter volume of whole brain
timeFrame: Baseline, 6,18,30 months later
measure: Change of white matter integrity of whole brain.
timeFrame: Baseline, 6,18,30 months later
measure: Change of metabolism of glucose in the brain
timeFrame: Baseline, 6,18,30 months later
measure: Change of functional connectivity of whole brain
timeFrame: Baseline, 6,18,30 months later
measure: Change of verbal learning and memory
timeFrame: Baseline, 6,18,30 months later
measure: Change of information processing speed
timeFrame: Baseline, 6,18,30 months later
measure: Change of executive function
timeFrame: Baseline, 6,18,30 months later
measure: Change of attention, verbal short term and working memory
timeFrame: Baseline, 6,18,30 months later
measure: Change of life quality.
timeFrame: Baseline, 6,18,30 months later
measure: Change of anxiety
timeFrame: Baseline, 6,18,30 months later
measure: Change of depression
timeFrame: Baseline, 6,18,30 months later
measure: Change of fatigue
timeFrame: Baseline, 6,18,30 months later
measure: Change of sleep
timeFrame: Baseline, 6,18,30 months later
Secondary outcomes:
measure: Change of the concentration of serum biomarkers.
timeFrame: Baseline, 6,18,30 months later
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Menghui Yuan, phd
role: PRINCIPAL_INVESTIGATOR
References: