Status:
COMPLETED
Effects of Diet and Exercise on Ductal Carcinoma in Situ
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Ductal Carcinoma In Situ
Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnose...
Detailed Description
Obesity is a known risk factor for invasive breast cancers that occur post-menopause. Obese women also die twice as frequently from breast cancer than those of normal weight. Numerous preclinical stud...
Eligibility Criteria
Inclusion
- Postmenopausal women with intermediate-to-high nuclear grade DCIS or stage I or II breast cancer who elect surgery and who have \>3-week lag-time between the start of the intervention and their scheduled surgery;
- Overweight or obese (BMI:25-60);
- English speaking/reading
- Willing to be assigned to either study arm
Exclusion
- Have a pre-existing medical condition(s) that preclude adherence to unsupervised exercise;
- Have a current medical condition that affects weight status;
- Has an active malignancy, other than DCIS, invasive breast cancer, or non-melanoma skin cancer;
- Currently enrolled in a weight loss program
- Have received or scheduled to receive neoadjuvant chemotherapy prior to mastectomy or lumpectomy
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02224807
Start Date
July 1 2014
End Date
July 1 2018
Last Update
August 31 2018
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294