CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Behavioral dietary intervention +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01819233
NCT01819233N/ACompleted
CompareCT.gov

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

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Mar 27, 2013·Updated Jun 6, 2025

In Brief

A clinical study evaluating Behavioral dietary intervention, Therapeutic conventional surgery, and 3 other interventions for Ductal Breast Carcinoma in Situ and 6 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuctal 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
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2013
Enrollment StartMar 8, 2013
Primary CompletionSep 14, 2017
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.3 years ago

Interventions

Behavioral dietary interventionbehavioral

Receive caloric restricted dietary intervention

Therapeutic conventional surgeryprocedure

Undergo definitive lumpectomy

Radiation therapyradiation

Undergo radiation therapy

Counseling interventionother

Receive dietary counseling

Quality-of-life assessmentprocedure

Ancillary studies