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Recruiting NCT05305092

Assessment of Brain Cognitive Impairment in Breast Cancer

— Observational Breast Cancer Chemo-brain Endocrine Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample.
Who it may be relevant to
Registry conditions: Breast Cancer, Chemo-brain, Endocrine Therapy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy

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.

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.

Interventions

  • Device PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
    Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.

Primary outcome measures

  • Change of gray matter volume of whole brain [Time frame: Baseline, 6,18,30 months later]
  • Change of white matter integrity of whole brain. [Time frame: Baseline, 6,18,30 months later]
  • Change of metabolism of glucose in the brain [Time frame: Baseline, 6,18,30 months later]
  • Change of functional connectivity of whole brain [Time frame: Baseline, 6,18,30 months later]
  • Change of verbal learning and memory [Time frame: Baseline, 6,18,30 months later]
  • Change of information processing speed [Time frame: Baseline, 6,18,30 months later]
  • Change of executive function [Time frame: Baseline, 6,18,30 months later]
  • Change of attention, verbal short term and working memory [Time frame: Baseline, 6,18,30 months later]
  • Change of life quality. [Time frame: Baseline, 6,18,30 months later]
  • Change of anxiety [Time frame: Baseline, 6,18,30 months later]
Secondary outcome measures (1)
  • Change of the concentration of serum biomarkers. [Time frame: Baseline, 6,18,30 months later]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Tangdu Hospital — Xi'an

Identifiers

NCT: NCT05305092 · 82071993

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗