TNBC Gut Microbiota During Neoadjuvant Treatment
Launched by SCRIPPS HEALTH · Sep 19, 2024
Trial Information
Current as of August 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a high-fiber diet may affect the gut microbiome in patients with early-stage triple-negative breast cancer (TNBC) who are receiving treatment before surgery. The gut microbiome is the community of tiny organisms living in our digestive system, and it can influence our overall health. Researchers want to find out if improving the gut microbiome through dietary changes, specifically by increasing fiber intake, can lead to better health outcomes for these patients. Up to 30 participants will be recruited to either follow a personalized high-fiber diet with guidance from a dietitian or receive educational handouts about nutrition during their treatment.
To be eligible for this study, participants must be at least 18 years old, diagnosed with early-stage TNBC, and not currently undergoing certain therapies. They should also be able to communicate in English at an 8th-grade level or higher. Throughout the trial, participants can expect nutritional counseling and support, along with tracking their physical activity and mood. After completing the study, participants will have one-on-one interviews to share their experiences and satisfaction with the supportive care they received. This trial aims to explore the connection between diet and gut health during cancer treatment, potentially offering new insights into how nutrition can support patients fighting breast cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment.
- • Age greater than or equal to 18 years and less than 100 years
- • English proficiency at or above 8th grade level
- • Expected survival greater than or equal to 12 months
- Exclusion Criteria:
- • Prebiotic and/or probiotic use prior to and during the study
About Scripps Health
Scripps Health is a leading nonprofit healthcare organization based in San Diego, California, dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence, Scripps Health integrates cutting-edge technology and evidence-based practices to explore new treatments and therapies across various medical disciplines. Their robust network of healthcare professionals and research specialists fosters a collaborative environment, enabling the development of groundbreaking solutions that enhance health outcomes for diverse patient populations. Through rigorous scientific inquiry and a patient-centered approach, Scripps Health continues to contribute significantly to the advancement of medical knowledge and the improvement of community health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Trial Officials
Lee Hong, MD, PhD
Principal Investigator
Scripps Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported