Nutritional Counseling for Breast Cancer

Overseen By Thomas Buchholz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Health

Must not be taking: Prebiotics, Probiotics

Disqualifiers: Non-early-stage TNBC, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 60

Duration: 24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-fiber diet can improve gut health in individuals with early-stage triple-negative breast cancer. Researchers are comparing two groups: one receiving personalized nutritional counseling (also known as dietary counseling or nutrition therapy) to increase fiber intake, and another receiving only a standard educational handout. They aim to determine if dietary changes affect the gut microbiome (the community of tiny organisms in the digestive system) during cancer treatment. This study targets those diagnosed with early-stage triple-negative breast cancer who have not yet begun treatment. Participants must understand English well and have a good prognosis of living for at least another year. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and cancer.

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 prior data suggests that nutritional counseling is safe for breast cancer patients?

Research has shown that dietary changes can positively affect breast cancer treatment. Consuming a healthy diet rich in whole grains, vegetables, fruits, nuts, and olive oil may help slow cancer growth and reduce side effects. For those with triple-negative breast cancer, studies suggest that a Mediterranean diet might lower the risk of cancer spreading to the lungs and reduce heart problems.

Nutritional counseling, which guides patients in making these dietary changes, is generally well-received. No strong evidence indicates any major negative effects from this counseling. Instead, it may improve health by boosting the body's response to cancer treatments and enhancing overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nutritional counseling for breast cancer because it offers a personalized approach to dietary changes, specifically focusing on increasing fiber intake. Unlike standard treatments that primarily involve surgery, chemotherapy, and radiation, this approach empowers patients with practical dietary strategies to potentially enhance their overall health and treatment outcomes. This counseling is distinctive because it provides tailored guidance through one-on-one sessions, helping patients make sustainable lifestyle changes that may support their recovery and well-being.

What evidence suggests that nutritional counseling might be an effective treatment for early-stage triple-negative breast cancer?

Studies have shown that diet can affect breast cancer outcomes. A plant-based diet, rich in fruits and whole grains, has been linked to a 15% lower risk of breast cancer. Reducing dietary fat may also decrease the chances of cancer recurrence. Although no specific diet exists for triple-negative breast cancer, consuming healthy foods like whole grains and vegetables is beneficial. The Mediterranean diet, rich in healthy fats, might help prevent heart problems and reduce the risk of cancer spreading to the lungs. In this trial, participants in the "High Fiber Dietary Counseling" arm will receive personalized nutritional counseling to guide them toward these healthy eating habits. Participants in the "Educational Handout" arm will receive an educational handout on increasing dietary fiber. ^{1 6 7 8 9}

Who Is on the Research Team?

Lee Hong, MD, PhD

Principal Investigator

Scripps Clinic

Are You a Good Fit for This Trial?

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

English proficiency at or above 8th grade level

Expected survival greater than or equal to 12 months

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo neoadjuvant chemotherapy +/- immunotherapy with personalized nutritional intervention or educational handout

24 weeks

Initial 60-minute telehealth consultation, up to two 30-minute follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including stool sample collection and survey completion

4 weeks

Post-study Interview

Participants are offered a one-on-one session to discuss their experiences and provide feedback

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Counseling

Trial Overview 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.

How Is the Trial Designed?

Group I: High Fiber Dietary Counseling Experimental Treatment 1 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 Handout Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Scripps Health

Lead Sponsor

Trials

59

Recruited

43,400+

The Scripps Research Institute

Collaborator

Trials

34

Recruited

12,400+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

Published Research Related to This Trial

A cluster-randomized clinical trial involving 468 cancer patients receiving radiotherapy showed that an evidence-based nutrition education and counseling (NEC) program significantly improved nutrition status, as indicated by lower PG-SGA scores (5.6 vs 6.9) and reduced malnutrition rates (56.0% vs 70.5%) compared to usual care.

The study demonstrates that implementing NEC in clinical settings can effectively reduce malnutrition among cancer patients undergoing treatment, highlighting its potential as a standard practice in radiotherapy units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. Zhang, Z., Zhu, Y., Zhang, L., et al.[2022]

Intensive individualized nutritional counseling for cancer patients is essential and should be conducted by nutrition professionals with specific oncology experience to ensure effective dietary management.

Nutritional supplements may be necessary when patients cannot meet their nutritional needs through regular foods, and these supplements should be tailored based on dietary deficits and individual patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional approaches in cancer: relevance of individualized counseling and supplementation. Ravasco, P.[2015]

Nutrition interventions can help cancer patients manage malnutrition caused by cancer and its treatments, improving their quality of life and providing a sense of control during a challenging time.

While definitive proof of efficacy may be lacking, these interventions are considered justified as long as they are safe and conducted with the patient's consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Intervention in Cancer. Heber, D., Li, Z.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11854917/

Dietary Interventions for Breast Cancer Prevention A diet rich in whole grains, fruits, vegetables, and lean proteins could potentially have a protective role for BC risk [12], reducing ROS ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9017973/

Diet impacts triple‐negative breast cancer growth ... Our data suggest that the Mediterranean diet may reduce lung metastatic lesions formation and prevent the development of cardiac toxicities.

3. medicalnewstoday.com medicalnewstoday.com/articles/triple-negative-breast-cancer-diet

What to know about triple-negative breast cancer and diet While research has not identified the ideal diet for triple-negative breast cancer, a nutritious diet rich in produce and whole grains may be beneficial.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523303034

Dietary fat reduction and breast cancer outcome The study determined that low-fat dietary interventions can influence body weight and decrease breast cancer recurrence.

5. cancer.ucsf.edu cancer.ucsf.edu/sites/cancer.ucsf.edu/files/_docs/crc/nutrition_breast.pdf

Nutrition and Breast Cancer A large cohort* study with over 91,000 women showed a plant-based diet was associated with a 15% reduction in breast cancer risk; this effect was even more ...

6. mdpi.com mdpi.com/2072-6643/11/7/1514

Nutrition and Breast Cancer: A Literature Review on ... Data from the published literature suggest that a healthy dietary pattern characterized by high intake of unrefined cereals, vegetables, fruit, nuts and olive ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724001943

Dietary interventions and tumor response to chemotherapy ... Narrative Review. Dietary interventions and tumor response to chemotherapy in breast cancer: A comprehensive review of preclinical and clinical data.

8. ifm.org ifm.org/articles/lifestyle-therapies-to-support-breast-cancer-treatment

Nutritional Strategies to Support Breast Cancer Treatment Explore nutrition and diet strategies that may help reduce side effects of breast cancer treatment and improve well-being.

9. academic.oup.com academic.oup.com/jnci/article/115/8/886/7172380

nutrition as prevention for improved cancer outcomes | JNCI ... However, high rates of malnutrition continue to affect health outcomes and are associated with increased risk of complications, lower treatment tolerance and ...