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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01819233
Recruitment Status : Completed
First Posted : March 27, 2013
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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
Procedure: Therapeutic conventional surgery
Radiation: Radiation therapy
Other: Counseling intervention
Procedure: Quality-of-life assessment
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Period Title: Overall Study
Started 38
Completed 32
Not Completed 6
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  86.8%
>=65 years
5
  13.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
38
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
4
  10.5%
Not Hispanic or Latino
33
  86.8%
Unknown or Not Reported
1
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
15
  39.5%
White
18
  47.4%
More than one race
0
   0.0%
Unknown or Not Reported
4
  10.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Number of Participants Who Are Adherent to the Diet Restriction
Hide Description Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.
Time Frame Up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
28 [1] 
(NA to 74.5)
[1]
one sided lower confidence limit as one-sided alpha used.
2.Secondary Outcome
Title Change in Body Fat Measurement
Hide Description Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique
Time Frame Baseline to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
patients who did not complete all assessments were not included in the analysis
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 29
Mean (95% Confidence Interval)
Unit of Measure: percentage of change in body fat
-3.1
(-4.7 to -1.5)
3.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time
Time Frame Baseline to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
participants who did not complete all timepoint measurements were not included.
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 31
Mean (95% Confidence Interval)
Unit of Measure: percentage of change in BMI
-1.2
(-1.6 to -0.8)
4.Secondary Outcome
Title Change in Heart Rate Over Time
Hide Description Assessed via mixed-effects regression.
Time Frame Baseline to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
only participants who completed all timepoints were included
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: beats per minute
67.3  (1.5)
5.Secondary Outcome
Title Patterns of Change Over Time in Serum Markers
Hide Description Assessed via mixed-effects regression.
Time Frame Baseline to 4 weeks after completion of study
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Hide Description Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)
Time Frame Baseline to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
patients who did not complete all questionnaire timepoints were not included in the analysis
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 31
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.8
(-6.2 to 7.8)
7.Secondary Outcome
Title Local Recurrence
Hide Description Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time Frame Up to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
8.Secondary Outcome
Title Distant Metastases
Hide Description Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time Frame Up to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
9.Secondary Outcome
Title Progression Free Survival
Hide Description Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time Frame Up to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
10.Secondary Outcome
Title Overall Survival
Hide Description Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time Frame Up to 4 weeks after completion of study
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient data was collected to conduct survival analysis as there were participants who were lost to follow up.
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description:

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
Time Frame baseline through 5 weeks after completion of study diet.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Dietary Intervention
Hide Arm/Group Description

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 QD 5 days a week for 6 weeks.

Behavioral dietary intervention: Receive caloric restricted dietary intervention

Therapeutic conventional surgery: Undergo definitive lumpectomy

Radiation therapy: Undergo radiation therapy

Counseling intervention: Receive dietary counseling

Quality-of-life assessment: Ancillary studies

All-Cause Mortality
Behavioral Dietary Intervention
Affected / at Risk (%)
Total   0/38 (0.00%)    
Hide Serious Adverse Events
Behavioral Dietary Intervention
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Behavioral Dietary Intervention
Affected / at Risk (%) # Events
Total   14/38 (36.84%)    
General disorders   
fatigue *  13/38 (34.21%)  38
hot flashes *  5/38 (13.16%) 
Skin and subcutaneous tissue disorders   
Dermatitis *  13/38 (34.21%)  38
hyperpigmentation *  10/38 (26.32%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nicole Simone
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-6702
EMail: nicole.simone@jefferson.edu
Publications:
Tannenbaum A. Effects of Varying Caloric Intake Upon Tumor Incidence and Tumor Growth. Annals of the New York Academy of Sciences. 15 Dec 2006 2006;49(1).
National Institutes of Health. http://www.clincaltrials.gov.
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01819233    
Other Study ID Numbers: 12G.616
2012-94 ( Other Identifier: CCRRC )
First Submitted: March 22, 2013
First Posted: March 27, 2013
Results First Submitted: October 29, 2019
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019