Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Breast Cancer

Estimated Enrollment:

14

Study ID:

NCT05265715

Recruitment Status:

Recruiting

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Lindsay Peterson, M.D., MSCR
Contact
314-273-3022
[email protected]
Lindsay Peterson, M.D., MSCR
Principal Investigator
Rosy Luo, Ph.D.
Sub-Investigator
Yikyung Park, ScD
Sub-Investigator
Suzanne Waller, M.D., RDN, LD
Sub-Investigator
Cameron Earnheart, RD, LD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

14

Study ID:

NCT05265715

Recruitment Status:

Recruiting

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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