Exploring cognitive impairment in breast cancer patients
Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
This study is trying to see if certain brain changes in young women with breast cancer who are undergoing chemotherapy and hormone therapy can help predict memory and thinking problems, so doctors can choose better treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Sex | Female |
| Sponsor | Tang-Du Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05305092 on ClinicalTrials.gov |
What this trial studies
This study investigates cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal women with breast cancer. It employs advanced multimodal integrated PET/MRI technology alongside psycho-behavioral assessments to observe changes in brain structure, function, and glucose metabolism. The goal is to identify biomarkers that can predict cognitive decline early, aiding in the rational selection of treatment plans for breast cancer patients. By understanding these cognitive effects, the study aims to improve patient care and outcomes.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women with primary stage I-II breast cancer who have not yet started treatment other than surgery.
Not a fit: Patients with central nervous system diseases, a history of malignancy, or conditions affecting cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better treatment strategies that minimize cognitive impairment in breast cancer patients.
How similar studies have performed: Other studies have shown success in exploring cognitive impairment in cancer patients, but this specific approach using integrated PET/MRI technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- Tangdu Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Menghui Yuan, phd — Tang-Du Hospital
- Study coordinator: Menghui Yuan, phd
- Email: yuanmenghui@163.com
- Phone: 0086-13519196610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.