NCT03120390

Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors

Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the effects of a 6-month progressive combined training (PCT) program on metabolic dysregulation (MetD) in centrally obese latina breast cancer survivors (LBCS). SECONDARY OBJECTIVES: I. To determine whether improved physical fitness and health-related measures from a 6-month PCT program are associated with reductions in MetD in centrally obese LBCS. II. To determine whether MetD status and physical fitness can be maintained following a 6-month follow-up period and to establish predictors of exercise behavior in LBCS. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I (PROGRESSIVE COMBINED TRAINING \[PCT\]): Patients undergo supervised exercise sessions comprising of aerobic exercise (AE) over 30 minutes and resistance exercise (RE) over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. GROUP II (PROGRESSIVE AEROBIC TRAINING \[PAT\]): Patients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. GROUP III (USUAL CARE): Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I. After completion of study, patients are followed up at 37 and 49 weeks.

Conditions

• Cancer Survivor
• Central Obesity
• No Evidence of Disease

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo usual care
BEHAVIORAL	Exercise Intervention	Undergo AE
BEHAVIORAL	Exercise Intervention	Undergo RE
OTHER	Laboratory Biomarker Analysis	Correlative studies
DEVICE	Monitoring Device	Receive Polar heart rate monitor
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-03-08
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2017-04-19
• Last updated: 2020-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study