Exploring gut microbiota in early-stage triple-negative breast cancer treatment
Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer
This study is testing whether personalized nutrition advice to increase fiber can help improve treatment outcomes for people with early-stage triple-negative breast cancer by looking at changes in their gut bacteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Scripps Health Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab, cyclophosphamide, doxorubicin |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06610097 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of the gut microbiome in patients with early-stage triple-negative breast cancer (TNBC) undergoing neoadjuvant treatment. It involves a randomized controlled approach where participants will receive either personalized nutritional counseling focused on increasing fiber intake or an educational handout on dietary changes. The study aims to understand how dietary modifications can influence the gut microbiome and potentially improve treatment outcomes. Data will be collected on various health metrics, including gastrointestinal symptoms, dietary intake, and mental health status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 100 diagnosed with early-stage triple-negative breast cancer who are not currently receiving neoadjuvant systemic therapy.
Not a fit: Patients who are using prebiotics or probiotics prior to or during the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this study could provide insights into how dietary interventions can enhance treatment outcomes for patients with triple-negative breast cancer.
How similar studies have performed: While the role of the gut microbiome in cancer treatment is an emerging field, this specific approach of dietary intervention in TNBC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California
- Scripps Clinic — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Lee Hong, MD, PhD — Scripps Clinic
- Study coordinator: Lee Hong, MD, PhD
- Email: hong.lee@scrippshealth.org
- Phone: 858-610-1321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.