← Back to Search

Behavioural Intervention

Nutritional Counseling for Breast Cancer

N/A

Waitlist Available

Led By Lee Hong, MD, PhD

Research Sponsored by Scripps Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years and less than 100 years

Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the gut microbiome in early-stage triple-negative breast cancer patients undergoing neoadjuvant treatment. The researchers will recruit 30 patients to compare the effects of a high-fiber

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include gastrointestinal discomfort due to increased fiber intake but are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have early-stage triple-negative breast cancer and am not on initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stool microbiome 16S bacterial species and diversity

Secondary study objectives

Activity level as measured on Rapid Assessment of Physical Activity scale

Anxiety as measured on Generalized Anxiety Disorder-7 scale

Depression as measured on Patient Health Questionnaire-9 scale.

+4 more

Other study objectives

Tumor gene expression analysis using GeoMx spatial transcriptional profiling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met