CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02827370|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma||Behavioral: Behavioral Dietary Intervention||Not Applicable|
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.
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 (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer|
|Actual Study Start Date :||June 16, 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Precision Nutrition (dietary intervention)
During chemotherapy, patients will receive dietary counseling based on the molecular pathways driving their specific breast cancers found through genetic testing. Nutritional recommendations will seek to down-regulate the dominant molecular drivers of an individual's breast cancer while they are receiving standard chemotherapy as outlined by their treating medical oncologist.
Behavioral: Behavioral Dietary Intervention
Receive dietary counseling
- Pathologic complete response assessed in tissue [ Time Frame: At time of definitive breast surgery ]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%.
- 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 [ Time Frame: Up to 24 months ]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
- Weight changes [ Time Frame: Up to 24 months ]Will be assessed by modeling body mass index as a function of time via mixed-effects regression.
- Change in insulin [ Time Frame: Up to 24 months ]Will be assessed as a function of time via mixed-effects regression.
- Change in serum [ Time Frame: Up to 24 months ]Will be assessed as a function of time via mixed-effects regression.
- Distant metastases [ Time Frame: Up to 24 months ]Will be analyzed via the Kaplan-Meier method and the logrank test.
- Progression-free survival [ Time Frame: Up to 24 months ]Kaplan-Meier curves will be generated and a log-rank value will be calculated.
- Overall survival [ Time Frame: Up to 24 months ]Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827370
|Contact: Nicole Simone, MD||215-955-6702|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Nicole Simone, MD|
|Principal Investigator:||Nicole Simone, MD||Thomas Jefferson University|