Nutritional Counseling for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot use prebiotics or probiotics before and during the study.
What data supports the effectiveness of the treatment Nutritional Counseling for Breast Cancer?
Is nutritional counseling safe for humans?
How does nutritional counseling differ from other treatments for breast cancer?
Nutritional counseling for breast cancer focuses on personalized dietary changes, such as reducing fat intake and increasing carbohydrates, to improve health outcomes and potentially reduce disease progression, unlike traditional treatments that may involve surgery, chemotherapy, or radiation.16101112
What is the purpose of 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.
Research Team
Lee Hong, MD, PhD
Principal Investigator
Scripps Clinic
Eligibility Criteria
This trial is for up to 30 patients with early-stage triple-negative breast cancer (TNBC) who are undergoing neoadjuvant treatment. Participants should be willing to potentially change their diet and provide stool samples. Specific inclusion or exclusion criteria aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo neoadjuvant chemotherapy +/- immunotherapy with personalized nutritional intervention or educational handout
Follow-up
Participants are monitored for safety and effectiveness after treatment, including stool sample collection and survey completion
Post-study Interview
Participants are offered a one-on-one session to discuss their experiences and provide feedback
Treatment Details
Interventions
- Nutritional Counseling
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scripps Health
Lead Sponsor
The Scripps Research Institute
Collaborator
San Diego State University
Collaborator