RecruitingNot ApplicableNCT04959474

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


Sponsor

Thomas Jefferson University

Enrollment

80 participants

Start Date

Aug 23, 2021

Study Type

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining pre-operative radiation (using a technique called SABR — stereotactic ablative radiotherapy) with a period of caloric restriction (eating fewer calories) before surgery for early-stage breast cancer is safe and may improve outcomes. There is some evidence that restricting calories temporarily can make cancer cells more sensitive to radiation. **You may be eligible if...** - You are 40 or older (or 50+ if you have triple-negative breast cancer) - You have confirmed early-stage breast cancer (DCIS or invasive) with a tumor 3 cm or smaller - Your cancer is in one location in the breast - Your lymph nodes appear normal on imaging or biopsy - You are in good general health (Karnofsky score 70–100) - Your BMI is 21 or above - You speak English or Spanish - You are not being considered for pre-operative chemotherapy **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - Your tumor is larger than 3 cm - You have had prior breast radiation on the same side - You have had any prior treatment (radiation or chemotherapy) for this breast cancer - You have significant psychiatric illness that would prevent you from following the protocol - Your BMI is below 21 Talk to your doctor to see if this trial is right for you.

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

OTHERBest Practice

Given standard dietary recommendations

RADIATIONStereotactic Body Radiation Therapy

Undergo SABR

PROCEDUREResection

Undergo surgical resection

PROCEDURESentinel Lymph Node Biopsy

Undergo sentinel lymph node biopsy

OTHERDietary Intervention

Undergo a caloric restriction diet

OTHERQuestionnaire Administration

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

PROCEDUREMammography

Undergo mammography

PROCEDUREBiospecimen Collection

Undergo blood, tissue, and rectal swab sample collection


Locations(1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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NCT04959474


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