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

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.

Description

Eligibility

Age range

40+ years

Sex

All

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

Location