TNBC Gut Microbiota During Neoadjuvant Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorScripps Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prebiotic and/or probiotic use prior to and during the study
Trial design
Design model
Parallel
Treatments tested in this trial
Nutritional Counseling
Other interventionThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Educational HandoutNo intervention 0 interventions
Group B: High Fiber Dietary CounselingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stool microbiome 16S bacterial species and diversity
Next generation sequencing
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.Secondary outcomes
1
Dietary intake - food categories
As measured on NCI-DSQ which assesses consumption of general food categories
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.2
Activity level as measured on Rapid Assessment of Physical Activity scale
To score RAPA 1, choose the question with the highest score with an affirmative response. Score as (1): I rarely or never do any physical activities. (2): I do some light or moderate physical activities, but not every week. (3): I do some light physical activity every week. (4): I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. OR I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. (5): I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week. To score RAPA 2, score as (1): I do activities to increase muscle strength, such as lifting weights or calisthenics, once a week or more. (2): I do activities to improve flexibility, such as stretching or yoga, once a week or more. (3) Both. (0) Neither. Add RAPA 1 and 2 for total. Min: 1; Max: 8. Higher score indicates greater activity level.
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.3
Depression as measured on Patient Health Questionnaire-9 scale.
9-question depression scale with each item scored 0 (not at all) to 3 (nearly every day). Min: 0; Max: 27. Higher score indicates greater severity of depression.
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.4
Anxiety as measured on Generalized Anxiety Disorder-7 scale
7-item questionnaire with each item scored 0 for not at all and 3 for nearly every day. Min: 0; Max: 21. Higher scores indicate greater severity of anxiety.
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.Other outcomes
1
Tumor gene expression analysis using GeoMx spatial transcriptional profiling
Up to 3 participants with high-fiber dietary intake who experience pathologic complete response (pCR) and 3 participants with residual disease (i.e. up to 6 total) will be selected based on retrospective chart review and biopsy samples pre- and post-treatment will be identified. Samples will be further processed and mounted onto slides, each with 1 participant with matched pre- and post-neoadjuvant treatment samples per slide for GeoMx spatial transcriptional profiling of 96 regions of interest (ROIs).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Scripps Health
Lead sponsor
San Diego State University
Collaborator
The Scripps Research Institute
Collaborator
Source ClinicalTrials.gov