Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer (NCT07574671) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
United States12 participantsStarted 2026-04-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ins…
What they're measuring
1
Change in tumor immune microenvironment
Timeframe: Baseline to 3 weeks
Trial details
NCT IDNCT07574671
SponsorThe University of Texas Health Science Center at San Antonio