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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 23 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Aug 2017 to primary completion in Jul 2019, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern California →