30 Participants Needed

Nutritional Counseling for Breast Cancer

LH
TB
Overseen ByThomas Buchholz, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scripps Health
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that nutritional counseling can improve nutritional status, reduce complications, and enhance quality of life for cancer patients, as seen in studies with colorectal and head and neck cancer patients undergoing radiotherapy.12345

Is nutritional counseling safe for humans?

Nutritional counseling, which involves guidance on healthy eating, has been studied in various contexts and is generally considered safe for humans. Studies have shown it can improve quality of life and nutritional intake without significant adverse effects.16789

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

LH

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

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

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

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+

Findings from Research

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.
Nutritional approaches in cancer: relevance of individualized counseling and supplementation.Ravasco, P.[2015]
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.
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]
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.
Nutrition Intervention in Cancer.Heber, D., Li, Z.[2017]

References

Nutritional approaches in cancer: relevance of individualized counseling and supplementation. [2015]
Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. [2022]
Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. [2022]
Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. [2022]
Nutrition Intervention in Cancer. [2017]
Individualized nutrition intervention is of major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled trial of nutritional therapy. [2023]
Dietary prevention of breast cancer. [2020]
Randomized trial of dietician counseling to try to prevent weight gain associated with breast cancer adjuvant chemotherapy. [2018]
Effect of 8-week nutrition counseling to increase phytochemical rich fruit and vegetable consumption in korean breast cancer patients: a randomized controlled trial. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Nutrition and breast cancer. [2017]
Dietary intervention in breast cancer patients: effects on dietary habits and nutrient intake. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Nutrition-related issues for the breast cancer survivor. [2019]
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