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Nutritional Counseling for Triple-Negative Breast Cancer During Treatment

This study is looking at how personalized nutritional counseling, focusing on increasing fiber and maintaining good calorie intake, affects the gut microbiome (the tiny living organisms in your digestive system) in people with early-stage triple-negative breast cancer. The gut microbiome is important for health and can change during cancer treatment, potentially affecting outcomes. This study aims to see if dietary changes can positively influence the gut microbiome during treatment. You may be eligible if you are 18 to 100 years old, have early-stage triple-negative breast cancer, and are not currently on systemic therapy. The study plans to enroll 30 participants. Success will be measured by changes in the types and diversity of bacteria in stool samples over 24 weeks.

Study design
This is a randomized pilot study with 30 participants. You would be randomly assigned to receive either personalized nutritional counseling or an educational handout.
What's involved
You would have an initial 60-minute telehealth consultation and up to two follow-up sessions for nutritional counseling. Stool samples will be collected at 0, 6, 12, 18, and 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your stool microbiome will be monitored for up to 24 weeks after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06610097

TNBC Gut Microbiota During Neoadjuvant Treatment

Withdrawn
NAAges 18+InterventionalBasic science
Scripps Health
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Nutritional Counseling

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stool microbiome 16S bacterial species and diversity
Measured over From date of enrollment and randomization, with collection at 0, 6, 12, 18, and 24 weeks after date of enrollment for up to 24 weeks.

Conditions

Breast Cancer
Triple Negative Breast Cancer
Early Stage Triple-Negative Breast Carcinoma

Explore related trials

Triple-negative breast cancer

NCT06610097

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Scripps Clinic

    La Jolla, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lee Hong, MD, PhD · PRINCIPAL_INVESTIGATOR · Scripps Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Prebiotic and/or probiotic use prior to and during the study

What this trial measures

  • Stool microbiome 16S bacterial species and diversityFrom date of enrollment and randomization, with collection at 0, 6, 12, 18, and 24 weeks after date of enrollment for up to 24 weeks.

    Next generation sequencing