An interventional study of Exercise Intervention and Exercise Intervention in Cancer Survivor, No Evidence of Disease and Obesity, sponsored by University of Southern California. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by University of Southern California · Not applicable, Interventional, and Supportive care
This randomized pilot clinical trial studies how well circuit, interval-based aerobic and resistance exercise works in targeting metabolic dysregulation in stage I-III breast or prostate cancer survivors. Circuit, interval-based aerobic and resistance exercise may help to improve cardiovascular fitness, weight loss, healthy lifestyle behaviors, and muscle strength in breast or prostate cancer survivors.
PRIMARY OBJECTIVES:
I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on metabolic dysregulation.
SECONDARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on skeletal muscle strength, physical fitness, and quality of life (QOL).
II. To determine the effects of a 4-month CARE intervention on vascular function.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during the CARE sessions.
Arm II: Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16 weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.
After completion of study, patients undergoing CARE are followed up for 4 months.
Exclusion Criteria:
Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during the CARE sessions.
Behavioral: Exercise Intervention · Other: Laboratory Biomarker Analysis · Other: Polar heart rate monitor · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16 weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.
Behavioral: Exercise Intervention · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo CARE
Undergo standard stretching program
Correlative studies
Receive Polar heart rate monitor
Also known as: Monitor
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Change in insulin resistance
Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin.
Time frame: Baseline up to week 34
Change in metabolic syndrome (Blood Pressure)
Blood pressure will be measured using an automated device with an appropriate sized cuff (Omron BP 786, Lake Forest, IL) after the participant has sat quietly for 5 minutes while resting his/her arm on a table so the brachial artery is level with the heart.
Time frame: Baseline up to week 34
Change in metabolic syndrome (Waist Circumference)
A tape measure will be used to obtain waist circumference defined as the distance around the waist using the umbilicus as the reference point.
Time frame: Baseline up to week 34
Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34.
Time frame: Baseline up to week 34
Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)
The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.
Time frame: Baseline up to week 34
Change in metabolic syndrome (Triglycerides)
The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.
Time frame: Baseline up to week 34
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Southern California