Study Summary
This trial will study whether a low AGE diet can improve breast cancer prognosis by looking at weight, known prognostic biomarkers, and novel prognostic biomarkers.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 15 Secondary · Reporting Duration: At study completion for all enrolled participants (estimated to be 15 months)
Week 24
Change in dietary AGE
Month 15
Feasibility as measured by adherence rate
Feasibility as measured by dropout rate
Week 24
Correlation between dietary AGE and BMI
Correlation between dietary AGE and IL6
Correlation between dietary AGE and adiponectin
Correlation between dietary AGE and glucose
Correlation between dietary AGE and insulin
Correlation between dietary AGE and leptin
Correlation between dietary AGE and serum CRP
Correlation between serum AGE levels and BMI
Correlation between serum AGE levels and IL6
Correlation between serum AGE levels and adiponectin
Correlation between serum AGE levels and glucose
Correlation between serum AGE levels and leptin
Correlation between serum AGE levels and serum CRP
Week 24
Change in serum AGE
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Low AGE dietary intervention
1 of 1
Experimental Treatment
14 Total Participants · 1 Treatment Group
Primary Treatment: Low AGE diet · No Placebo Group · N/A
Low AGE dietary interventionExperimental Group · 2 Interventions: Low AGE diet, Research blood draw · Intervention Types: Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Research blood draw
2018
Completed Phase 2
~100
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at study completion for all enrolled participants (estimated to be 15 months)
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,601 Total Patients Enrolled
42 Trials studying Breast Cancer
8,195 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
213 Previous Clinical Trials
98,164 Total Patients Enrolled
31 Trials studying Breast Cancer
8,859 Patients Enrolled for Breast Cancer
Lindsay Peterson, M.D., MSCRPrincipal InvestigatorWashington University School of Medicine
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have 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).
You have a dietary AGE intake greater than 14 Eq/day.
You are able to understand and are willing to sign an IRB approved informed consent document.
You are at least 18 years of age.
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Conditions
Cancer Related
Treatments