Clinical trial · Interventional
TNBC Gut Microbiota During Neoadjuvant Treatment
Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patients were able to be enrolled
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early Stage Triple-Negative Breast Carcinoma | Early Stage Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional Counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Educational Handout
- description
- Participants will receive usual standard of care for early-stage triple negative breast cancer and an educational handout on increasing dietary fiber.
- type
- EXPERIMENTAL
- label
- High Fiber Dietary Counseling
- description
- 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.
- interventionNames
- Other: Nutritional Counseling
Primary outcomes (1)
- measure
- Stool microbiome 16S bacterial species and diversity
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDJandhyala 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
- BACKGROUNDKok 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
- BACKGROUNDFrak 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
- BACKGROUNDJotshi 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
- BACKGROUNDSpencer CN, McQuade JL, Gopalakrishnan V, McCulloch JA, Vetizou M, Cogdill AP, Khan MAW, Zhang X, White MG, Peterson CB, Wong MC, Morad G, Rodgers T, Badger JH, Helmink BA, Andrews MC, Rodrigues RR, Morgun A, Kim YS, Roszik J, Hoffman KL, Zheng J, Zhou Y, Medik YB, Kahn LM, Johnson S, Hudgens CW, Wani K, Gaudreau PO, Harris AL, Jamal MA, Baruch EN, Perez-Guijarro E, Day CP, Merlino G, Pazdrak B, Lochmann BS, Szczepaniak-Sloane RA, Arora R, Anderson J, Zobniw CM, Posada E, Sirmans E, Simon J, Haydu LE, Burton EM, Wang L, Dang M, Clise-Dwyer K, Schneider S, Chapman T, Anang NAS, Duncan S, Toker J, Malke JC, Glitza IC, Amaria RN, Tawbi HA, Diab A, Wong MK, Patel SP, Woodman SE, Davies MA, Ross MI, Gershenwald JE, Lee JE, Hwu P, Jensen V, Samuels Y, Straussman R, Ajami NJ, Nelson KC, Nezi L, Petrosino JF, Futreal PA, Lazar AJ, Hu J, Jenq RR, Tetzlaff MT, Yan Y, Garrett WS, Huttenhower C, Sharma P, Watowich SS, Allison JP, Cohen L, Trinchieri G, Daniel CR, Wargo JA. Dietary fiber and probiotics influence the gut microbiome and melanoma immunotherapy response. Science. 2021 Dec 24;374(6575):1632-1640. doi: 10.1126/science.aaz7015. Epub 2021 Dec 23.