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

Withdrawn before enrolling · Not applicable

Conditions studied: Cancer Survivor, Central Obesity, No Evidence of Disease

In brief

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.

Key facts

Study ID

NCT03120390

Run by

University of Southern California

People needed

0

Starts

2019-03-08

Expected to finish

2019-07-31

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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