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Low AGE Diet for Breast Cancer
N/A
Waitlist Available
Led By Lindsay Peterson, M.D., MSCR
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion for all enrolled participants (estimated to be 15 months)
Awards & highlights
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.
Who is the study for?
This trial is for breast cancer survivors, aged 18 or older, who have finished primary therapy within the last 3 years and consume a high-AGE diet. They must understand and sign consent forms. Exclusions include those in other dietary trials, with diabetes, active tobacco use, eating disorders, or taking certain AGE-inhibiting medications.Check my eligibility
What is being tested?
The study tests if a low Advanced Glycation End-product (AGE) diet can affect weight and biomarkers related to breast cancer prognosis. Participants' diets will be altered to reduce AGE intake. The study also involves blood draws to measure the impact of this dietary change.See study design
What are the potential side effects?
Since this is a dietary intervention trial focusing on reducing AGE intake through food choices rather than medication or invasive procedures, side effects are minimal but may include changes in digestion or food preferences.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion for all enrolled participants (estimated to be 15 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion for all enrolled participants (estimated to be 15 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility as measured by adherence rate
Feasibility as measured by dropout rate
Secondary outcome measures
Change in dietary AGE
Change in serum AGE
Correlation between dietary AGE and BMI
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Low AGE dietary interventionExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Research blood draw
2022
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,811 Total Patients Enrolled
46 Trials studying Breast Cancer
5,154 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,441 Total Patients Enrolled
32 Trials studying Breast Cancer
8,870 Patients Enrolled for Breast Cancer
Lindsay Peterson, M.D., MSCRPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently involved in other research studies or community programs related to diet or exercise.You have been diagnosed with diabetes.You are currently smoking or using tobacco products.You have a history of eating disorder or feeling very unhappy about your body.You are currently taking and cannot stop taking certain medications that are known to inhibit AGEs.You eat a lot of foods that have advanced glycation end products (AGEs), which can be harmful to your health.You have had breast cancer and finished treatment for it, including surgery, radiation, and chemotherapy, at least 4 weeks ago. You can still be taking hormonal therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Low AGE dietary intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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