Condition: Breast Cancer · Triple Negative Breast Cancer · Early Stage Triple-Negative Breast Carcinoma · Sponsor: Scripps Health
The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food, extracting vitamins and nutrients from food, and maintaining a healthy gut lining. The gut microbiome plays an important role in overall health and has been shown to dynamically change in response to early-stage triple-negative breast cancer-directed therapies, which in turn has been associated with worse outcomes. As the gut microbiome can be further modulated with dietary changes during cancer treatment, it is an ideal potential modifiable risk factor in cancer patients. However, due to multiple confounding factors such as dietary intake, mood, and activity, its utility as part of the oncologic clinical assessment remains unclear. In this prospective randomized controlled study, the investigators propose to recruit up to 30 early-stage TNBC patients to randomize to a personalized nutritional intervention of a high-fiber diet coached by a registered dietician versus educational handout alone during neoadjuvant treatment. The investigators propose to study the gut microbiota through stool sample analysis among early-stage triple-negative breast cancer patients undergoing neoadjuvant (i.e. before surgery) chemotherapy +/- immunotherapy. The investigators will also study how the gut microbiota can be further modulated with a high-fiber diet, and the investigat…
This description comes directly from the study's public registry record.
Lee Hong, MD, PhD · 858-610-1321 · hong.lee@scrippshealth.org
Thomas Buchholz, MD · 858-678-7190 · buchholz.thomas@scrippshealth.org
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| Scripps Clinic | La Jolla, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06610097