Exercise program to improve health in obese Latina breast cancer survivors
Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: the ROSA Trial
This study is testing whether a 16-week exercise program can help Latina breast cancer survivors improve their fitness and reduce their risk of heart disease, diabetes, and obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04717050 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a 16-week exercise program on fitness and risk factors for heart disease, diabetes, and obesity in Latina breast cancer survivors. Participants will be randomly assigned to either a Progressive Combined Training (PCT) group, which includes supervised and unsupervised exercise sessions, or an Attention Control group that focuses on home-based stretching. The study aims to assess the sustainability of the exercise program within this population and includes multiple evaluations and follow-up visits over a 12-month period. The goal is to determine if the exercise intervention can effectively improve health outcomes for these survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who have been newly diagnosed with Stage I-III breast cancer and are centrally obese.
Not a fit: Patients who are not newly diagnosed with breast cancer or who do not meet the obesity criteria may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the health and quality of life for obese Latina breast cancer survivors by reducing their risk factors for chronic diseases.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer survivors, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * Patients with other active malignancies are ineligible for this study. * Patients with metastatic disease * Is not centrally obese as defined above * Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis * History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise * Participates in more than 60 minutes of structured exercise/week * Is planning reconstructive surgery with flap repair during trial and follow-up period * Currently smokes * Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection * 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.