Recruiting NCT07574671
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Ketogenic diet
The ketogenic diet will be comprised of a low carbohydrate, high fat diet.
Primary outcome measures
- Change in tumor immune microenvironment [Time frame: Baseline to 3 weeks]
Secondary outcome measures (3)
- ketone level [Time frame: Baseline to 3 weeks]
- EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3) [Time frame: Baseline to 3 weeks]
- Fact B (The Functional Assessment of Cancer Therapy - Breast) [Time frame: Baseline to 3 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mays Cancer Center, UT Health San Antonio — San Antonio
Identifiers
NCT: NCT07574671 · CTMS# 25-0144