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NCT06610097 · ClinicalTrials.gov registry record · NA
TNBC Gut Microbiota During Neoadjuvant Treatment
A NA study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Scripps Health.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06610097: Recruiting NA study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Scripps Health.
NCT06610097 is a NA study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Scripps Health. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06610097, a NA study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Scripps Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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 investigators hypothesize that a high-fiber diet may play a protective role in preserving gut microbial diversity. As part of the nutritional intervention, the investigators propose to administer nutritional counseling with a registered dietitian (RD) to increase fiber intake and tracking performance status, activity, and mood during neoadjuvant treatment. Finally, the investigators propose to survey participants after study completion through one-on-one interviews to determine whether participants experi
Conditions Studied
Interventions
- OTHER Nutritional Counseling
Study Locations (1)
California
- Scripps Clinic - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-03-07 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT06610097 shows while recruiting
NCT06610097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Nutritional Counseling is the first listed.
NCT06610097 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06610097 about?
NCT06610097 is a clinical study titled "TNBC Gut Microbiota During Neoadjuvant Treatment". 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 lini...
What is the current status of trial NCT06610097?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-03-07. Estimated completion is 2026-06-30.
What conditions does trial NCT06610097 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, Early Stage Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT06610097?
The interventions under investigation include: Nutritional Counseling (OTHER).
Who is sponsoring clinical trial NCT06610097?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06610097 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06610097's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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