Nutritional Counseling for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byLee Hong, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Scripps Health

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

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

I am at least 18 years old but younger than 100.

English proficiency at or above 8th grade level

Expected survival greater than or equal to 12 months

+1 more

Exclusion Criteria

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

Participant Groups

The study tests if a high-fiber diet, guided by nutritional counseling from a registered dietician, can positively affect the gut microbiota compared to just receiving an educational handout during cancer treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: High Fiber Dietary CounselingExperimental Treatment1 Intervention

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.

Group II: Educational HandoutActive Control1 Intervention

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