UCLA Breast Cancer Survivor Health Promotion Research Study

Breast Cancer Clinical Trial

Official title:

A Fiber-diverse, Anti-inflammatory Diet and Aerobic Exercise Reduce Risk of Breast Cancer Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113485
• Other study ID #: B27IB3856
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: University of California, Los Angeles
• Contact: William J. McCarthy, Ph.D.
• Phone: 3107947587
• Email: wmccarth[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life.

Description:

Background. The human gut microbiota influences obesity status and inflammation, two major risk factors for postmenopausal breast cancer recurrence. Whether an exercise and dietary intervention designed to optimize gut microbiota composition might reduce risk for breast cancer recurrence is unknown. To improve the gut microbiota composition, the investigators propose teaching postmenopausal breast cancer survivors to allocate about 20% of their daily calorie intake to consuming a daily count of six fiber-rich, minimally processed, plant-based food choices that comply with federal MyPlate.gov diet recommendations. Preliminary data suggest that the investigators' Highly-Microbiota-Accessible Foods (HMAFs) approach will yield cardiometabolic outcomes equal to or better than those achieved by the traditional Diabetes Prevention Program (DPP) calorie restriction approach at 6 months follow-up. Because breast cancer recurrence risk covaries with cardiometabolic risks, the lower cardiometabolic risk of the HMAFs approach should be associated with reduced risk of breast cancer recurrence. Hypotheses. The greater diversity of fiber-rich, minimally processed plant foods consumed in the HMAFs condition relative to the DPP condition will result in greater changes in HMAFs participants compared to DPP participants from baseline to 6 months follow-up in the following measures: (primary hypothesis) reduce high sensitivity C-reactive protein, (secondary hypotheses) reduce visceral body fat and increase alpha-1 diversity of gut microbes and increase health-related quality of life. To test these hypotheses, the research objectives include the following specific aims: 1) Recruit a diverse sample of 30 overweight or obese postmenopausal survivors with stage I, II and IIIa breast cancer; randomly allocate them to two lifestyle change intervention conditions, 2) Obtain baseline and 6-month follow-up assessments of: low grade systemic inflammation, body composition including visceral fat estimation, cardiorespiratory fitness, inflammatory and cardiometabolic biomarkers, fecal samples, and quality of life, 3) Conduct two parallel, three-month behavior change interventions, contrasting the 6-count HMAFs approach with the traditional DPP calorie restriction approach , and 4) Use results to design a ramped-up randomized factorial trial. If hypotheses are confirmed, the low-numeracy HMAFs approach may, for low-income survivors, be a practical alternative to traditional high-numeracy calorie restriction approaches to reducing risk of breast cancer recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. At least 6 months since breast cancer diagnosis and up to 4 years since diagnosis.

2. Between 50 and 75 years of age.

3. Diagnosed with localized steroid hormone receptor-positive breast cancer, up to stage IIIa.

4. At least 6 months post chemotherapy or radiation treatment.

5. Subjects must be in good health as determined by medical history, physical examination, and clinical laboratory measurements.

6. No broad-spectrum antibiotic use in the last two months.

7. Body mass index between 27 and 38 based on self-reported height and weight and between 25 and 40 based on objective assessment of height and weight.

8. Willing to complete assessments at baseline, 3 months and 6 months follow-up

Exclusion Criteria:

1. Diagnosed with metastatic breast cancer

2. Currently undergoing chemotherapy or radiation treatment

3. Immunoglobulin-E (IgE)-mediated food allergies, or any medical condition requiring mandatory dietary restrictions

4. Significant cardiac, pulmonary, renal, liver or psychiatric disease.

5. Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Diabetes Prevention Program-based lifestyle change intervention (DPP)
The DPP condition consists of 11 health education sessions over 12 weeks, including 2 virtual home visits, two virtual group education sessions and 7 telephone coaching calls. These sessions will teach DPP-based lessons on how to lose excess body fat through calorie restriction and increased physical activity. All dietary and physical activity recommendations are intended to be consistent with federal nutrition and physical activity guidelines.
• Highly Microbiota-Accessible Foods (HMAFs) intervention
The Highly Microbiota-Accessible Foods (HMAFs) intervention approach includes 11 health education sessions, including two virtual home visits, two virtual group education sessions, and 7 telephone coaching sessions. These sessions are designed to help study participants to identify and consume optimally 6 daily instances of minimally processed, fiber-rich food sources, drawn from all four of the MyPlate.gov categories: vegetables, fruits, whole grains and plant-based protein-rich foods (e.g., legumes, nuts and seeds). Increased physical activity is also recommended as a way to optimize the microbial conversion of fiber-rich food sources to short chain fatty acids, which are then expected to reduce excess low-grade inflammation.

Locations

Country	Name	City	State
United States	UCLA Center for Cancer Prevention & Control Research	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin resistance	Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) is a recognized measure of insulin resistance, calculated from fasting glucose and fasting insulin values	Change from baseline to six months follow-up
Other	Waist circumference	Waist circumference is measured via non-stretchable measuring tape around the waist at a midpoint between the lowest rib and the iliac crest, upon breath exhalation.	Change from baseline to six months follow-up
Other	Body mass index (BMI)	Height measured via wall-mounted stadiometer and weight measured via calibrated digital scale will be used to compute BMI ((kg/(m x m))	Change from baseline to six months follow-up
Other	Systolic blood pressure (mm)	Regularly calibrated digital sphygmomanometer will be used to assess the participant's resting systolic blood pressure in millimeters of mercury	Change from baseline to six months follow-up
Other	Ratio of abundance of fecal Proteobacteria to fecal short chain fatty acid-generating bacteria	Fecal DNA from the V4 region of the 16S ribosomal RNA will be amplified, sequenced and filtered for quality before statistical analysis. The ratio of fecal Proteobacterial abundance to the abundance of short-chain fatty acid-generating fecal microbes is expected to be reduced in healthier guts.	Change from baseline to six months follow-up
Other	Health-related quality of life	RAND Short Form-20 (SF-20) is recognized instrument for assessing participants' health-related quality of life. Minimum score = 0; maximum score = 100. Higher scores represent higher quality of life.	Change from baseline to six months follow-up
Other	HDL-cholesterol	Fasting serum HDL-cholesterol concentration expected to reflect the experimental differences in dietary patterns. Serum triglycerides will be generated as part of a standard lipid panel.	Change from baseline to six months follow-up
Primary	High-sensitivity C-Reactive Protein (CRP)	CRP is commonly used by researchers as a biomarker for systemic inflammation.	Change from baseline to 6 months follow-up
Secondary	Visceral fat as assessed by DXA	Visceral fat is also known as intra-abdominal fat. It is located inside the peritoneal cavity, packed in between internal organs and torso. It is the most metabolically active adipose tissue and positively associated with systemic inflammation.	Change from baseline to six months follow-up
Secondary	Shannon index of alpha diversity of fecal microbial species	Fecal DNA from the V4 region of the 16S ribosomal RNA will be amplified, sequenced and filtered for quality before statistical analysis. The Shannon index measures both gene richness and evenness.	Change from baseline to six months follow-up
Secondary	Number of highly microbiota-accessible foods consumed per day	From participants' 24-hour diet recalls - The daily sum of different carbohydrate-rich food sources minimally processed and unaccompanied by pro-inflammatory components, especially saturated fat and added sugar.	Change from baseline to six months follow-up