TNBC Gut Microbiota During Neoadjuvant Treatment

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT06610097
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Nutritional Counseling — OTHER
    The nutritional intervention for the treatment group -- personalized counseling on increasing fiber intake and maintaining adequate caloric intake during treatment -- will be administered as (1) a 60-minute initial telehealth consultation within the first week of study enrollment, and (2) up to two 30-minute follow-ups throughout the study, ideally the first follow-up within 6 weeks of study enrollment. These sessions will be led by a registered dietitian using cultural awareness and symptom assessment.

Study Details

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 experienced improved overall patient satisfaction in supportive care during their treatment.

Key Dates

Start date
Mar 7, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Educational Handout
    Participants will receive usual standard of care for early-stage triple negative breast cancer and an educational handout on increasing dietary fiber.
  • Experimental: High Fiber Dietary Counseling
    Participants will receive usual standard of care for early-stage triple negative breast cancer and personalized nutritional counseling (initial 1 hour session with up to 2 30-minute follow-up sessions) on how to increase dietary fiber.

Primary Outcome Measure

Stool microbiome 16S bacterial species and diversity [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps ClinicLa JollaCalifornia92037
Lee Hong, MD, PhD
[email protected]
858-554-8788
Thomas Buchholz, MD
[email protected]
Lee Hong, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jacob New, MD, PhD (SUB_INVESTIGATOR)
Gagandeep Kaur, DO (SUB_INVESTIGATOR)
Laura Nicholson, MD, PhD (SUB_INVESTIGATOR)

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