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RECRUITING
NCT04959474
NA

Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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

Interventions

OTHER

Best Practice

Given standard dietary recommendations

RADIATION

Stereotactic Body Radiation Therapy

Undergo SABR

PROCEDURE

Resection

Undergo surgical resection

PROCEDURE

Sentinel Lymph Node Biopsy

Undergo sentinel lymph node biopsy

OTHER

Dietary Intervention

Undergo a caloric restriction diet

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Mammography

Undergo mammography

PROCEDURE

Biospecimen Collection

Undergo blood, tissue, and rectal swab sample collection

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States