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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT04959474
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage 0 Breast Cancer AJCC v8
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Anatomic Stage 2 Breast Cancer AJCC v8
  • Anatomic Stage 3 Breast Cancer AJCC v8
  • Breast Ductal Carcinoma in Situ
  • Invasive Breast Carcinoma
  • Triple Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Given standard dietary recommendations
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SABR
  • Resection — PROCEDURE
    Undergo surgical resection
  • Sentinel Lymph Node Biopsy — PROCEDURE
    Undergo sentinel lymph node biopsy
  • Dietary Intervention — OTHER
    Undergo a caloric restriction diet
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Mammography — PROCEDURE
    Undergo mammography
  • Biospecimen Collection — PROCEDURE
    Undergo blood, tissue, and rectal swab sample collection

Study Details

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.

Key Dates

Start date
Aug 23, 2021
Status verified
Jan 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (standard dietary recommendations, SABR, surgery)
    Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
  • Experimental: Arm II (caloric restriction diet, SABR, surgery)
    Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.

Primary Outcome Measure

Percent reduction in cellularity of breast tumor [ Time Frame: 4-16 weeks, depending on the date of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Nicole Simone, MD
[email protected]
215-955-6702

Find similar trials in Philadelphia, PA

By research site
Thomas Jefferson University Hospital· Philadelphia, PA

Related Studies