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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
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion for all enrolled participants (estimated to be 15 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion for all enrolled participants (estimated to be 15 months) for reporting.

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 more

Trial 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
2017
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,074 Total Patients Enrolled
46 Trials studying Breast Cancer
5,154 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,443 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

Media Library

Low AGE diet Clinical Trial Eligibility Overview. Trial Name: NCT05265715 — N/A
Breast Cancer Research Study Groups: Low AGE dietary intervention
Breast Cancer Clinical Trial 2023: Low AGE diet Highlights & Side Effects. Trial Name: NCT05265715 — N/A
Low AGE diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265715 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for potential participants in this clinical trial?

"According to the clinicaltrials.gov database, this study is still recruiting participants and was originally posted on October 14th 2022 with its most recent edit being made on October 19th 2022."

Answered by AI

What objectives is this clinical trial hoping to accomplish?

"The purpose of this 15-month clinical trial is to evaluate the feasibility of adherence. Secondary assessments involve examining the connection between dietary AGE and insulin, serum AGE levels and BMI, as well as changes in dietary AGE with a 3 day food record compiled at baseline and study completion under the advisement of Jaime Uribarri MD."

Answered by AI

How many volunteers are participating in this clinical experiment?

"This is correct. According to clinicaltrials.gov, the study first went up on October 14th 2022 and was recently modified on October 19th 2022; furthermore, only 14 subjects are required at a single location for enrollment in this trial."

Answered by AI
~0 spots leftby Mar 2024