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Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
Sponsor: Thomas Jefferson University
Summary
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.
Official title: SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2021-08-23
Completion Date
2028-11-01
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Given standard dietary recommendations
Stereotactic Body Radiation Therapy
Undergo SABR
Resection
Undergo surgical resection
Sentinel Lymph Node Biopsy
Undergo sentinel lymph node biopsy
Dietary Intervention
Undergo a caloric restriction diet
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Mammography
Undergo mammography
Biospecimen Collection
Undergo blood, tissue, and rectal swab sample collection
Locations (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States