The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Primary objective: I To determine if dietary alternations designed to downregulate the dominate molecular drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy and allow for an increase in the pathologic complete response rate. Secondary objectives I) Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Receive dietary counseling
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, United States
Pathologic complete response assessed in tissue
The portion of patients who adhere to the diet restriction will be computed along with a 95% exact confidence. An exact binomial test (with a onesided alpha of 0.05) will also be used to test whether adherence is greater than 60%.
Time frame: At time of definitive breast surgery
Incidence of adverse events evaluated by CTCAE version 4.0
Time frame: Up to 24 months
Number of study participants who receive the dietary intervention to the historical controls
Will be compared to historical controls. Will be based on logistic regression, which will control for patient characteristics and clinical factors. The study has 81% power to detect an odds ratio of about 0.25 using a 2-sided alpha of 0.05
Time frame: Up to 24 months
Weight changes
Will be assessed by modeling body mass index as a function of time via mixed-effects regression.
Time frame: Up to 24 months
Change in insulin
Will be assessed as a function of time via mixed-effects regression.
Time frame: Up to 24 months
Change in serum
Will be assessed as a function of time via mixed-effects regression.
Time frame: Up to 24 months
Distant metastases
Will be analyzed via the Kaplan-Meier method and the logrank test.
Time frame: Up to 24 months
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Progression-free survival
Kaplan-Meier curves will be generated and a log-rank value will be calculated.
Time frame: Up to 24 months
Overall survival
Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression.
Time frame: Up to 24 months