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Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy

NCT01819233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-06

Study results available
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Summary

This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.

Conditions

  • Ductal Breast Carcinoma in Situ
  • Invasive Ductal Breast Carcinoma
  • Invasive Lobular Breast Carcinoma
  • Lobular Breast Carcinoma in Situ
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer

Interventions

BEHAVIORAL

Behavioral dietary intervention

Receive caloric restricted dietary intervention

PROCEDURE

Therapeutic conventional surgery

Undergo definitive lumpectomy

RADIATION

Radiation therapy

Undergo radiation therapy

OTHER

Counseling intervention

Receive dietary counseling

PROCEDURE

Quality-of-life assessment

Ancillary studies

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Nicole Simone, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-08
Primary Completion
2017-09-14
Completion
2019-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819233 on ClinicalTrials.gov