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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet Treatment arm | Experimental | Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Other | The ketogenic diet will be comprised of a low carbohydrate, high fat diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in tumor immune microenvironment | Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment | Baseline to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ketone level | percent time serum ketones ≥ 0.5 mmol/L | Baseline to 3 weeks |
| EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3) |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Terrones | Contact | 210-450-5098 | terronesj@uthscsa.edu | |
| Kayla Chamberlin, RN, BSN | Contact | 210-450-5964 | chamberlink@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Saba Shaikh, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mays Cancer Center, UT Health San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Prospective, single-institution, window study
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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.
| Baseline to 3 weeks |
| 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) | Baseline to 3 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |