Assessment of Brain Cognitive Impairment in Breast Cancer

Recruiting

• Conditions: Endocrine Therapy; Chemo-brain; Breast Cancer
• Interventions: Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample

• Registration Number: NCT05305092
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13
• Primary Completion: 2027-05-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample	Healthy non-cancer controls
Endocrine therapy	PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample	Premenopausal breast cancer patients receiving endocrine therapy alone after surgery
chemotherapy	PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample	Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery

Primary Outcome Measures

Name	Time	Method
Change of attention, verbal short term and working memory	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.
Change of life quality.	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.
Change of gray matter volume of whole brain	Baseline, 6,18,30 months later	Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Change of white matter integrity of whole brain.	Baseline, 6,18,30 months later	Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Change of metabolism of glucose in the brain	Baseline, 6,18,30 months later	Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography
Change of sleep	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.
Change of functional connectivity of whole brain	Baseline, 6,18,30 months later	Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence
Change of verbal learning and memory	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.
Change of fatigue	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.
Change of information processing speed	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.
Change of executive function	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.
Change of anxiety	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.
Change of depression	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.

Secondary Outcome Measures

Name	Time	Method
Change of the concentration of serum biomarkers.	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

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China