Assessment of Brain Cognitive Impairment in Breast Cancer

NCT05305092 | Recruiting

• 1 other identifier: 82071993
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemo-brain; Endocrine Therapy

Keywords

CRCI; psycho-behavioral technology; Integrated PET/MRI technology; Biomarkers

Outcome Measures

Primary Outcomes (13)

• Change of gray matter volume of whole brain

  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.

  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

  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

  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

  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

  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

  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

  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.

  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

  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

  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

  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

  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 Outcomes (1)

• Change of the concentration of serum biomarkers.

  Baseline, 6,18,30 months later

Study Arms (3)

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

Endocrine therapy

Premenopausal breast cancer patients receiving endocrine therapy alone after surgery

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

Healthy control

Healthy non-cancer controls

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

Interventions

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.

Endocrine therapy; Healthy control; chemotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Premenopausal patients with stage I-II breast cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead
• Xi'an Jiaotong University: collaborator

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, gut microbiota

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Menghui Yuan, phd

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menghui Yuan, phd

CONTACT

0086-13519196610; yuanmenghui@163.com

Lijun Bai, phd

CONTACT

0086-15129034948; bailijun@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 31, 2022
• Study Start: May 31, 2022
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

CN (1)