Clinical trial NCT05265715: A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors
Official title: A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-03-03
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Feasibility as measured by adherence rate
timeFrame: At study completion for all enrolled participants (estimated to be 15 months)
measure: Feasibility as measured by dropout rate
timeFrame: At study completion for all enrolled participants (estimated to be 15 months)
Secondary outcomes:
measure: Change in dietary AGE
timeFrame: At baseline and study completion (24 weeks)
measure: Change in serum AGE
timeFrame: Baseline, week 12, and week 24
measure: Correlation between serum AGE levels and BMI
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between serum AGE levels and serum CRP
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between serum AGE levels and IL6
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between serum AGE levels and glucose
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between serum AGE levels and leptin
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between serum AGE levels and adiponectin
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and BMI
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and serum CRP
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and IL6
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and insulin
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and glucose
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and leptin
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Correlation between dietary AGE and adiponectin
timeFrame: Baseline, 12 weeks, and 24 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay Peterson, M.D., MSCR
role: PRINCIPAL_INVESTIGATOR
References: