A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors

NCT05265715 | Completed DMC

• 1 other identifier: 202201100
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific premise for this study is the known impact of overweight/obesity on breast cancer risk and outcomes, the association between advanced glycation end-products (AGE) and high fat, highly processed foods common in Western diets, and the preclinical evidence suggesting a link between AGE and breast cancer independent of weight. The association between dietary and serum AGE in breast cancer survivors and prognosis has not been previously evaluated. However, preclinical studies suggest that AGE may represent a novel, lifestyle-linked, modifiable, prognostic biomarker, which could be targeted through lifestyle (diet and exercise) and/or pharmaceutical interventions to improve breast cancer prognosis. The proposed study will pave the way for a large scale randomized controlled trial to evaluate the impact of a low AGE diet on weight (BMI), known (IL-6 and CRP) and novel (AGE and RAGE) prognostic biomarkers, and ultimately on breast cancer prognosis.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility as measured by adherence rate

  * Feasibility is a defined adherence rate of at least 80% of participants enrolled * Diet adherence will be categorized by the study dietitian at the end of the study and before the results of AGEs in serum or any analysis of outcomes to avoid bias. Following each phone session with the participants, the dietitian will elicit answers to the following question: since the last call did the participant use any cooking methods they were advised to avoid for certain food items? (yes/no). * The information will be used to calculate an adherence score. Adherence score is % phone calls of patient's report for full maintaining instructions to reduce AGEs. * Very high adherence= ≥80%; good adherence= 60-80%; partial adherence= 40-60%; lack of adherence but intention to adhere more in the future= ≤40%; lack of adherence and no intention to adhere more= ≤40%

  At study completion for all enrolled participants (estimated to be 15 months)

• Feasibility as measured by dropout rate

  -Feasibility is defined as a dropout rate of less than 20% of participants enrolled

  At study completion for all enrolled participants (estimated to be 15 months)

Secondary Outcomes (15)

• Change in dietary AGE

  At baseline and study completion (24 weeks)

• Change in serum AGE

  Baseline, week 12, and week 24

• Correlation between serum AGE levels and BMI

  Baseline, 12 weeks, and 24 weeks

• Correlation between serum AGE levels and serum CRP

  Baseline, 12 weeks, and 24 weeks

• Correlation between serum AGE levels and IL6

  Baseline, 12 weeks, and 24 weeks

Study Arms (1)

Low AGE dietary intervention

EXPERIMENTAL

* Patients will complete a food frequency questionnaire, \& if found to have a high AGE diet at baseline, will then begin the study the 24-week low AGE dietary intervention. Patients will complete a 3 day food record prior to receiving remotely delivered education on AGEs on how to adhere to a low AGE diet by the study dieticians prior to starting. This session will provide education on dietary AGE \& how to prepare \& choose low AGE meals * Subsequent sessions with the dieticians will be conducted remotely \& will be 30-60 minutes in duration, with the exception of sessions scheduled for weeks when a study blood draw is required, when visits with the dietician may occur in person. These sessions will occur at the following schedule: weekly during the first 2 months (8 sessions), every other week during the next 2 months (4 sessions, aka step down sessions), monthly for the remaining 2 months (2 sessions) * 3 day food records will be collected at 12 \& 24 weeks, in addition to baseline.

Other: Low AGE diet; Procedure: Research blood draw

Interventions

Low AGE diet OTHER

The recommended daily AGE intake will be either: * 7,500 kilounits \[ku\], which is a 50% reduction from the average 15,000 ku consumed by most adults or * a 50% reduction from their baseline AGE intake (based on 3-day food AGE record)

Low AGE dietary intervention

Research blood draw PROCEDURE

Baseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)

Low AGE dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of breast cancer, any subtype, stage I-III, within the last 36 months, who have completed primary therapy of their breast cancer (surgery, radiation, and chemotherapy). Must be at least 4 weeks post their last chemotherapy or radiation therapy. Concurrent hormonal therapy is allowed.
• At least 18 years of age.
• Determined to have a high AGE diet at baseline (dietary AGE intake greater than 14 Eq/day as assessed by food frequency questionnaire).
• Ability to understand and willingness to sign an IRB approved written informed consent document.

You may not qualify if:

• Diagnosis of diabetes.
• History of eating disorder or body dysmorphic disorder.
• Active tobacco use (tobacco is a source of advanced glycation end products).
• Active participation in other dietary or physical activity clinical trials or community interventions.
• Taking and unwilling/unable to stop taking B-6 (pyridoxamine), B1 (thiamine) or metformin (all known AGE inhibitors).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lindsay Peterson, M.D., MSCR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 3, 2022
• Study Start: October 14, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article presentation.
• Access Criteria: Proposals should be directed to llpeterson@wustl.edu.

Locations

US (1)