Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
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
Thomas Jefferson University
80 participants
Aug 23, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Given standard dietary recommendations
Undergo SABR
Undergo surgical resection
Undergo sentinel lymph node biopsy
Undergo a caloric restriction diet
Ancillary studies
Ancillary studies
Undergo mammography
Undergo blood, tissue, and rectal swab sample collection
Locations(1)
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NCT04959474