Clinical trial · Interventional
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)
NCT03120390CI-TRIAL-00048876withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Central Obesity | — | UNRESOLVED | — |
| No Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Monitoring Device | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I (PCT)
- description
- Patients undergo supervised exercise sessions comprising of AE over 30 minutes and 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.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Device: Monitoring Device
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group II (PAT)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed (stage I-III) breast cancer * Self-identify as Latina * Have undergone a lumpectomy or mastectomy * Have received and completed neoadjuvant or adjuvant cytotoxic chemotherapy and/or radiation therapy within the past 12 months * Have no evidence of cancer disease after treatment (confirmed by their treating physician) * Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; obtains clearance from physician to confirm status) * Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) \> 30 kg/m\^2 (calculated using height and weight) or body fat \> 30% (estimated by bioelectrical impedance), and waist circumference \> 35 inches (in) * Free from history of chronic disease including severe diabetes (glycosylated hemoglobin \[HgA1c\] \> 7% requiring a pharmacologic intervention), uncontrolled hypertension or thyroid disease (obtains clearance from physician to confirm status) * Have not experienced a weight reduction \>= 10% within past 6 months; and body weight has remained stable for the past 4 weeks * Currently participate in less than 60 minutes of physical activity/week * No planned reconstructive surgery with flap repair during trial and follow-up period * May use adjuvant endocrine therapy if use will be continued for duration of study period * Does not smoke (no smoking during previous 12 months) * Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided) Exclusion Criteria: * Currently pregnant * History of chronic disease including uncontrolled diabetes, uncontrolled hypertension or uncontrolled thyroid disease; women using metformin to manage diabetes will be excluded from the trial * Weight reduction \>= 10% within past 6 months * Metastatic disease * Planned reconstructive surgery with flap repair during trial and follow-up period * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
References
Publications (0)
Data not yet available
No reference posted for this study.