Lifestyle Intervention for Metastatic Breast Cancer
(EDC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have any recent or planned changes in their cancer treatments.
What data supports the effectiveness of the treatment Lifestyle Intervention for Metastatic Breast Cancer?
Research suggests that lifestyle interventions, including diet and physical activity, can improve quality of life and reduce symptom burden in women with metastatic breast cancer. These interventions may also offer additional health benefits, such as better physical functioning and reduced risk of other diseases like diabetes and heart disease.12345
Is the lifestyle intervention for metastatic breast cancer safe for humans?
How is the Lifestyle Intervention treatment for metastatic breast cancer different from other treatments?
The Lifestyle Intervention treatment for metastatic breast cancer is unique because it focuses on comprehensive lifestyle changes, including diet and physical activity, rather than traditional medical treatments. This approach is novel as it aims to improve quality of life and potentially influence disease outcomes by addressing multiple lifestyle factors, which have not been extensively tested in this patient group before.12346
What is the purpose of this trial?
This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).
Research Team
Melinda Stolley, PhD
Principal Investigator
Principal Investigator
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immediate Intervention
Participants receive a 16-week lifestyle intervention promoting nutritional and physical activity changes, including lifestyle coaching, exercise sessions, and cooking classes.
Attention Control
Participants receive a home/work organization intervention with weekly topics, virtual or phone calls, and text messages.
Follow-up
Participants are monitored for safety and effectiveness after the intervention, with data collection continuing up to 8 months.
Treatment Details
Interventions
- Attention Control
- Lifestyle Intervention
Lifestyle Intervention is already approved in United States, European Union for the following indications:
- Obesity
- Weight Loss
- Type 2 Diabetes Prevention
- Obesity
- Overweight
- Weight-Related Diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Loyola University Chicago
Collaborator