Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04717050
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Christina Dieli-Conwright, PhD, MPH
Phone	617-582-8321
Email	ChristinaM_Dieli-Conwright@dfci.harvard.edu
Status	Recruiting
Phase	N/A
Start date	August 12, 2021
Completion date	June 15, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms