Assessment of Brain Cognitive Impairment in Breast Cancer

NCT ID: NCT05305092

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2027-05-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Chemo-brain Endocrine Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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chemotherapy

Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menghui Yuan, phd

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Locations

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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Menghui Yuan, phd

Role: CONTACT

0086-13519196610

Lijun Bai, phd

Role: CONTACT

0086-15129034948

Facility Contacts

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Menghui Yuan, PHD

Role: primary

0086-13519196610

Lijun Bai, PHD

Role: backup

0086-15129034948

Other Identifiers

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82071993

Identifier Type: -

Identifier Source: org_study_id

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