NCT07574671招募中不适用
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Saba Shaikh
Assistant Professor
The University of Texas Health Science Center at San Antonio
研究点 (1)
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