Assessment of Brain Cognitive Impairment in Breast Cancer

July 12, 2022 updated by: Tang-Du Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Premenopausal patients with stage I-II breast cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chemotherapy
Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery
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.
Endocrine therapy
Premenopausal breast cancer patients receiving endocrine therapy alone after surgery
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.
Healthy control
Healthy non-cancer controls
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 6,18,30 months later
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)
Baseline, 6,18,30 months later
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
Baseline, 6,18,30 months later
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
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later
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.
Baseline, 6,18,30 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6,18,30 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Collaborators

Health Science Center of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Menghui Yuan, phd, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Anticipated)

May 30, 2027

Study Completion (Anticipated)

May 30, 2027

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82071993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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