This study is testing the effects of a ketogenic diet on patients with early stage breast cancer. Participants will keep to a ketogenic diet for 3 weeks prior to surgery.
Be willing and able to provide consent for the study
Age ≥ 18 on the day consent is obtained
Eastern Cooperative Oncology Group (ECOG) score ≤ 2
Patients must be postmenopausal the time of study entry
Clinical indication for neoadjuvant therapy
Partial mastectomy or mastectomy planned for less than 3 weeks from study entry
Inability to comply with ketogenic diet
Consistent use of ketogenic diet within past 3 months
Single group
Ketogenic diet
Other interventionThe ketogenic diet will be comprised of a low carbohydrate, high fat diet.
Change in tumor immune microenvironment
Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment
ketone level
percent time serum ketones ≥ 0.5 mmol/L
EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3)
A 30 item instrument used to assess some of the different aspects that define the quality of life of cancer patients. The first 28 items are scored from 1=Not at all to 4=Very much and the last 2 items (reverse scored) rate overall quality of health and life from 1=Very poor to 7=Excellent. Total scores can range from 30-126 with a higher score indicating a better quality of life.
Fact B (The Functional Assessment of Cancer Therapy - Breast)
The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item with each item scored from 0=Not at all to 4=Very much. The instrument is designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS) with total scores ranging from 0 to 148 (higher is better)
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The University of Texas Health Science Center at San Antonio
Lead sponsor
National Cancer Institute (NCI)
Collaborator
