TNBC Gut Microbiota During Neoadjuvant Treatment

NCT06610097 | Recruiting

• 1 other identifier: 24-8410
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

gut microbiome; triple-negative breast cancer; high fiber diet; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Stool microbiome 16S bacterial species and diversity

  Next generation sequencing

  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.

Secondary Outcomes (7)

• Dietary intake - food categories

  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.

• Activity level as measured on Rapid Assessment of Physical Activity scale

  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.

• Depression as measured on Patient Health Questionnaire-9 scale.

  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.

• Anxiety as measured on Generalized Anxiety Disorder-7 scale

  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.

• Gastrointestinal symptoms

  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.

Other Outcomes (1)

• Tumor gene expression analysis using GeoMx spatial transcriptional profiling

  1 year

Study Arms (2)

Educational Handout

NO INTERVENTION

Participants will receive usual standard of care for early-stage triple negative breast cancer and an educational handout on increasing dietary fiber.

High Fiber Dietary Counseling

EXPERIMENTAL

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.

Other: Nutritional Counseling

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.

High Fiber Dietary Counseling

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Health: lead
• San Diego State University: collaborator
• The Scripps Research Institute: collaborator

Study Sites (1)

Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

Related Publications (10)

• Jandhyala SM, Talukdar R, Subramanyam C, Vuyyuru H, Sasikala M, Nageshwar Reddy D. Role of the normal gut microbiota. World J Gastroenterol. 2015 Aug 7;21(29):8787-803. doi: 10.3748/wjg.v21.i29.8787.

  PMID: 26269668 BACKGROUND

• Kok CR, Rose D, Hutkins R. Predicting Personalized Responses to Dietary Fiber Interventions: Opportunities for Modulation of the Gut Microbiome to Improve Health. Annu Rev Food Sci Technol. 2023 Mar 27;14:157-182. doi: 10.1146/annurev-food-060721-015516. Epub 2022 Nov 29.

  PMID: 36446139 BACKGROUND

• Frak M, Grenda A, Krawczyk P, Milanowski J, Kalinka E. Interactions between Dietary Micronutrients, Composition of the Microbiome and Efficacy of Immunotherapy in Cancer Patients. Cancers (Basel). 2022 Nov 14;14(22):5577. doi: 10.3390/cancers14225577.

  PMID: 36428677 BACKGROUND

• Jotshi A, Sukla KK, Haque MM, Bose C, Varma B, Koppiker CB, Joshi S, Mishra R. Exploring the human microbiome - A step forward for precision medicine in breast cancer. Cancer Rep (Hoboken). 2023 Nov;6(11):e1877. doi: 10.1002/cnr2.1877. Epub 2023 Aug 4.

  PMID: 37539732 BACKGROUND

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  PMID: 34941392 BACKGROUND

• Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

  PMID: 32101663 BACKGROUND

• Thompson FE, Midthune D, Kahle L, Dodd KW. Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms. J Nutr. 2017 Jun;147(6):1226-1233. doi: 10.3945/jn.116.246058. Epub 2017 May 10.

  PMID: 28490673 BACKGROUND

• Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.

  PMID: 8445433 BACKGROUND

• Hajj-Boutros G, Landry-Duval MA, Comtois AS, Gouspillou G, Karelis AD. Wrist-worn devices for the measurement of heart rate and energy expenditure: A validation study for the Apple Watch 6, Polar Vantage V and Fitbit Sense. Eur J Sport Sci. 2023 Feb;23(2):165-177. doi: 10.1080/17461391.2021.2023656. Epub 2022 Jan 31.

  PMID: 34957939 BACKGROUND

• Kurian SM, Gordon S, Barrick B, Dadlani MN, Fanelli B, Cornell JB, Head SR, Marsh CL, Case J. Feasibility and Comparison Study of Fecal Sample Collection Methods in Healthy Volunteers and Solid Organ Transplant Recipients Using 16S rRNA and Metagenomics Approaches. Biopreserv Biobank. 2020 Oct;18(5):425-440. doi: 10.1089/bio.2020.0032. Epub 2020 Aug 21.

  PMID: 32833508 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lee Hong, MD, PhD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Hong, MD, PhD

CONTACT

858-610-1321; hong.lee@scrippshealth.org

Thomas Buchholz, MD

CONTACT

858-678-7190; buchholz.thomas@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 24, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)