Breast Cancer
Conditions
Keywords
Ketogenic diet, diet, nutrition
Brief summary
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.
Detailed description
After screening for eligibility participants will meet with a dietitian who will provide education on a ketogenic diet (KD) along with additional educational material. Patients will adhere to a ketogenic diet for 3 weeks. Serum glucose and ketones will be measured by patients daily to assess adherence to KD. Patients will also keep a daily diary that will note food intake along with physical activity.
Interventions
OTHERKetogenic diet
The ketogenic diet will be comprised of a low carbohydrate, high fat diet.
Sponsors
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, single-institution, window study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Stage I or II breast cancer using Tumor, Nodes and Metastasis (TNM) stage groups per American Joint Committee on Cancer (AJCC) 8th edition * Plan for upfront breast surgery with mastectomy or partial mastectomy and does not require pre-operative systemic therapy per standard of care * Must have tissue available from initial breast biopsy performed per standard of care * have the ability in the opinion of the investigator to adhere to a ketogenic diet and comply with study requirements such as ability to participate in telemedicine, utilize apps on a smart device, measure glucose/ketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet
Exclusion criteria
* 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 * Participation in another diet program during study period * Nonepithelial breast malignancy such as sarcoma or lymphoma * Body Mass Index \< 18.5 * Comorbidities and/or active or ongoing illness that in the opinion of the investigator will limit patient's ability to safely participate in study * Type I diabetes * Use of insulin or other oral hypoglycemic drugs for diabetes * Has had any of the following within the past 6 months * Myocardial infarction or unstable angina * Ventricular arrythmia * Acute decompensated heart failure * Cerebrovascular accident * Hypertensive emergency * Uncontrolled hypertension despite antihypertensive use * End-stage renal, liver, or cardiac disease * genetic disorders that affect lipid metabolism (example: pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, among others) * G6PD (glucose-6-phosphate dehydrogenase) deficiency * Malabsorption syndromes (such as but not limited to inflammatory bowel disease, history of gastric sleeve, prior bowel resection) * History of recurrent kidney stones or predisposition to kidney stones * Triglycerides ≥ 500 * Has known psychiatric or substance use disorders that would interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tumor immune microenvironment | Baseline to 3 weeks | Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ketone level | Baseline to 3 weeks | 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) | Baseline to 3 weeks | 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) | Baseline to 3 weeks | 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) |
Countries
United States
Contacts
CONTACTJoseph Terrones
CONTACTKayla Chamberlin, RN, BSN
PRINCIPAL_INVESTIGATORSaba Shaikh, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed