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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
Receive caloric restricted dietary intervention
Undergo definitive lumpectomy
Undergo radiation therapy
Receive dietary counseling
Ancillary studies
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Number of Participants Who Are Adherent to the Diet Restriction
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
Change in Body Fat Measurement
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
Change in Body Mass Index (BMI)
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
Change in Heart Rate Over Time
Assessed via mixed-effects regression.
Time frame: Baseline to 4 weeks after completion of study
Patterns of Change Over Time in Serum Markers
Assessed via mixed-effects regression.
Time frame: Baseline to 4 weeks after completion of study
Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
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
Local Recurrence
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
Distant Metastases
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
Progression Free Survival
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
Overall Survival
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
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