Assessment of Brain Cognitive Impairment in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305092
• Other study ID #: 82071993
• Status: Recruiting
• Start date: May 31, 2022
• Est. completion date: May 30, 2027

Study information

• Verified date: July 2022
• Source: Tang-Du Hospital
• Contact: Menghui Yuan, phd
• Phone: 0086-13519196610
• Email: yuanmenghui[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 30, 2027
• Est. primary completion date: May 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemo-brain
• Cognitive Dysfunction
• Endocrine Therapy

Intervention

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.

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	School of Life Science and Technology, Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change of the concentration of serum biomarkers.	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-1ß with pg/mL, TNF-a 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