NCT04717050Completed
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 19 Jan 2021
- Start date
- 23 Sept 2021
- Primary completion date
- 21 Jan 2025
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Obesity, Coronary artery disease, Stroke
- NCT number
- NCT04717050
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 23 Sept 2021 to the primary completion date, 21 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- Is planning reconstructive surgery with flap repair during trial and follow-up period
Other illness
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
Other
- Is not centrally obese as defined above
- Participates in more than 60 minutes of structured exercise/week
- Currently smokes
- Weight reduction ≥ 10% within past 6 months
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Who the study is looking for
- Women newly diagnosed (Stage I-III) breast cancer.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Are centrally obese with the following criteria\[84\] (determined by study team at eligibility screening): BMI \>30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat \>30% (estimated by bioelectrical impedance), and waist circumference \>35 in.
- Have undergone a lumpectomy or mastectomy.
- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
- Speak English or Spanish
- Self-identify as Latina
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
- Have not experienced a weight reduction ≥10% within the past 6 months
- Currently participate in less than 60 minutes of structured exercise/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 intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- Ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.