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NCT Number: NCT05305092

Assessment of Brain Cognitive Impairment in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemo-brain Endocrine Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.

Primary outcomes

  1. Change of gray matter volume of whole brain

    Time frame: Baseline, 6,18,30 months later

    Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)

  2. Change of white matter integrity of whole brain.

    Time frame: Baseline, 6,18,30 months later

    Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)

  3. Change of metabolism of glucose in the brain

    Time frame: Baseline, 6,18,30 months later

    Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography

  4. Change of functional connectivity of whole brain

    Time frame: Baseline, 6,18,30 months later

    Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence

  5. Change of verbal learning and memory

    Time frame: Baseline, 6,18,30 months later

    Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.

  6. Change of information processing speed

    Time frame: Baseline, 6,18,30 months later

    Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome.

  7. Change of executive function

    Time frame: Baseline, 6,18,30 months later

    Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome.

  8. Change of attention, verbal short term and working memory

    Time frame: Baseline, 6,18,30 months later

    Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.

  9. Change of life quality.

    Time frame: Baseline, 6,18,30 months later

    Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome.

  10. Change of anxiety

    Time frame: Baseline, 6,18,30 months later

    Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.

  11. Change of depression

    Time frame: Baseline, 6,18,30 months later

    Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.

  12. Change of fatigue

    Time frame: Baseline, 6,18,30 months later

    Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome.

  13. Change of sleep

    Time frame: Baseline, 6,18,30 months later

    Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.

Secondary outcomes

  1. Change of the concentration of serum biomarkers.

    Time frame: Baseline, 6,18,30 months later

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lijun Bai, phd

CONTACT

[email protected]

0086-15129034948

Menghui Yuan, phd

CONTACT

[email protected]

0086-13519196610

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Collaborators

  • Xi'an Jiaotong University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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