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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01426 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0S-17-5 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (CARE) | Experimental | 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. |
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| Arm II (standard stretching) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Undergo CARE |
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| Exercise Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance | Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin. | 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. | 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. | 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. | 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. | Baseline up to week 34 |
| Change in metabolic syndrome (Triglycerides) | The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34. | Baseline up to week 34 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Behavioral |
Undergo standard stretching program |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Polar heart rate monitor | Other | Receive Polar heart rate monitor |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D011471 | Prostatic Neoplasms |
| D057185 | Sedentary Behavior |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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