This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.
• Patients with pathologically proven DCIS or invasive breast cancer histologies
Willing and able to provide informed consent
Willing and able to comply with study treatments including dietary intervention
Body mass index (BMI) >= 21 at time of enrollment
Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative
Patient has stage IV metastatic disease
Breast tumor size is > 3.0 cm
Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
Parallel
Best Practice
Other interventionGiven standard dietary recommendations
Stereotactic Body Radiation Therapy
RadiationUndergo SABR
Resection
Procedure/SurgeryUndergo surgical resection
Sentinel Lymph Node Biopsy
Procedure/SurgeryUndergo sentinel lymph node biopsy
Dietary Intervention
Other interventionUndergo a caloric restriction diet
Questionnaire Administration
Other interventionAncillary studies
Quality-of-Life Assessment
Other interventionAncillary studies
Mammography
Procedure/SurgeryUndergo mammography
Biospecimen Collection
Procedure/SurgeryUndergo blood, tissue, and rectal swab sample collection
Percent reduction in cellularity of breast tumor
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
Feasibility of identifying sentinel lymph node (SLN)
Sentinel lymph node biopsy performed at the time of surgical resection per standard institutional protocol including dual tracer SLN identification. The first 10 enrolled patients who have a SLN biopsy performed (decided per institutional protocol and surgeon standard practice)will be assessed to determine the feasibility of identifying sentinel lymph node after pre-operative SABR and if the rate of SLN mapping is not at least 95% the trial will be closed to accrual and modified to reflect the safety and feasibility of finding the sentinel node.
Global physiologic assessment
Weight, height, and body composition will be assessed. Calipers will be used to assess biceps, triceps, scapula, and hips. Bioimpedence will be used to measure percent body fat and muscle mass.
Change in patient-reported health-related quality of life
Psycho-social evaluation will be done using the Patient Reported Outcomes Measurement Information System cancer fatigue short form, the National Comprehensive Cancer Network distress thermometer, and Functional Assessment of Cancer Therapy-Breast measure to determine how the interventions affect the patients prior to intervention, just before surgery, and end of treatment visit post SABR completion.
Physician cosmesis evaluation
Physicians will evaluate cosmesis using the excellent, good, fair, poor scale at the times specified in the Study Schedule.
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