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Lifestyle Intervention for Metastatic Breast Cancer (EDC Trial)
N/A
Recruiting
Led By Melinda Stolley, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (≥ 18 years), female
Confirmed Metastatic Breast Cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
EDC Trial Summary
This trial will explore how diet and activity impact breast cancer patients' health, body composition, and quality of life. 176 women in Milwaukee & Chicago will be studied.
Who is the study for?
This trial is for adult women with metastatic breast cancer who don't follow ACS nutrition or physical activity guidelines, have a mobile phone, and permission from their oncologist to participate. They must be clinically stable even with treated brain metastases, not losing weight unintentionally, no new symptoms or worsening condition in the past month, and expected to live more than 6 months.Check my eligibility
What is being tested?
The study tests a lifestyle program focusing on diet and exercise patterns against an attention control group. It aims to understand how these factors affect body composition, blood markers, and quality of life in women with metastatic breast cancer across two cities.See study design
What are the potential side effects?
Since this is a lifestyle intervention study rather than medication-based treatment, side effects may include typical responses to changes in diet or exercise such as muscle soreness or digestive adjustments but are generally expected to be minimal.
EDC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
Select...
My breast cancer has spread to other parts of my body.
EDC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body composition
Change in Quality of Life
Intervention adherence
+1 moreSecondary outcome measures
Serum Biomarker Adipokine Dysregulation - Adiponectin
Serum Biomarker Adipokine Dysregulation - Leptin
Serum Biomarker Inflammation - C-Reactive Protein
+5 moreOther outcome measures
nRNA and Metabolomics - exploratory
EDC Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate InterventionExperimental Treatment1 Intervention
The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes:
1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.
Group II: Attention ControlExperimental Treatment1 Intervention
The attention control participants will receive a home/work organization intervention:
Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter.
Virtual or weekly phone calls- with a home organization coach with standard prompts.
Text messages supporting home/work organization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attention Control
2014
Completed Phase 2
~6520
Lifestyle Intervention
2001
Completed Phase 2
~8880
Find a Location
Who is running the clinical trial?
Loyola University ChicagoOTHER
20 Previous Clinical Trials
12,412 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,407 Total Patients Enrolled
14 Trials studying Breast Cancer
409,343 Patients Enrolled for Breast Cancer
Melinda Stolley, PhDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Breast Cancer
240 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mobile phone.I have brain metastases but am stable after treatment.I am a woman aged 18 or older.My breast cancer has spread to other parts of my body.My health has been stable for the last 4 weeks with no severe pain or worsening symptoms.You haven't been following the recommended diet and exercise guidelines for cancer survivors based on a questionnaire.You do not fit the requirements mentioned earlier.You are expected to live for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control
- Group 2: Immediate 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants needed for this trial?
"Affirmative. The information available on clinicaltrials.gov indicates that this medical experiment, initially posted on November 1st 2022, is actively recruiting participants. 176 patients need to be enrolled from a solitary site for the study's completion."
Answered by AI
How many participants is this research endeavor accommodating?
"Affirmative, the current information on clinicaltrials.gov demonstrates that this experiment is actively seeking participants. The trial was first shared in November 1st 2022 and most recently updated December 16th 2022. This research necessitates 176 subjects over a single location to be enrolled."
Answered by AI
What is the primary purpose of this research endeavor?
"The primary goal of this 8-month research project is to examine body composition. The secondary objectives involve analyzing serum biomarkers related to inflammation (Tumor Necrosis Factor - alpha and C-Reactive Protein) as well as adipokine dysregulation (Leptin), all utilizing EVE technologies with standard ELISA kits."
Answered by AI
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