Understanding and Predicting Breast Cancer Events After Treatment

  • STATUS
    Recruiting
  • End date
    Jul 31, 2034
  • participants needed
    1000
  • sponsor
    Wake Forest University Health Sciences
Updated on 25 August 2021
stage iv breast cancer
female breast cancer

Summary

This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.

Description

840 women aged 18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.

Measurements will be repeated at 31, 122 and 242 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Observational, Data Collection, Cardiac MRI, Assessments
Clinical Study IdentifierNCT02791581
SponsorWake Forest University Health Sciences
Last Modified on25 August 2021

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