NCT01819233

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

A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: 1. Investigate the feasibility of a clinical trial administering ionizing radiation with concurrent caloric restriction (CR) for the treatment of breast cancer. SECONDARY OBJECTIVE: 2. Investigate measurable changes of patient characteristics and tissue and serum from CR conditions to determine a metric for evaluating this treatment in future studies. OUTLINE: Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy once daily (QD) 5 days a week for 6 weeks.

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

Type	Name	Description
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

Timeline

• Start date: 2013-03-08
• Primary completion: 2017-09-14
• Completion: 2019-09-01
• First posted: 2013-03-27
• Last updated: 2025-06-06
• Results posted: 2019-12-23

Locations

1 site across 1 country: United States