NCT04717050

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control. * Progressive combined training (PCT) will be performed in 2 phases: 1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom. 2. unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer. * Attention Control Group: 51 weeks home-based stretching All participants will undergo seven blood draws and participate in nine testing visits. Participation is expected to last 12 months for all participants. It is expected that about 160 people will take part in this research study. The American Cancer Society is supporting this research study by providing funding for the research study.

Conditions

• Breast Cancer
• Coronary Artery Disease
• Stroke
• Type2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Progressive combine training (PCT)	8 month exercise program with 4 month follow up.
BEHAVIORAL	Attention Control (AC)	12 month stretching program

Timeline

• Start date: 2021-08-12
• Primary completion: 2025-06-30
• Completion: 2026-06-15
• First posted: 2021-01-20
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States