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

Launched by DANA-FARBER CANCER INSTITUTE · Jan 19, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how exercise can help improve fitness and reduce health risks related to heart disease, diabetes, and obesity in Latina women who have survived breast cancer. The researchers want to see if a structured exercise program can make a positive difference for these survivors, especially those who have recently completed treatment for breast cancer.

To be eligible for the study, participants must be women over 18 who have been newly diagnosed with Stage I-III breast cancer and are currently in remission. They should have a high body mass index (BMI) or waist measurement, indicating obesity, and cannot be engaging in more than 60 minutes of structured exercise each week. Participants will need to travel to the Dana-Farber Cancer Institute for the program and will be required to sign an informed consent form explaining the study. Those who fit the criteria can expect to take part in a supervised exercise program designed to help improve their overall health and well-being.

Gender

FEMALE

Eligibility 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.