Cancer SurvivorNCT03284346
Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Polar heart rate monitor in people with Cancer Survivor and No Evidence of Disease, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, No Evidence of Disease, Obesity
- What is being tested?
- Exercise Intervention, Laboratory Biomarker Analysis and Polar heart rate monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2017to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BREAST CANCER COHORT:
- Women newly diagnosed (stage I-III) breast cancer
- Are overweight or obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 25 kg/m^2 (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 completed cancer-related treatment within the past 3 years
- Speak English or Spanish
Show all 19Show fewer
- Are 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 (fasting blood glucose > 125 mg/dL), hypertension (blood pressure > 130/90 mmHg) or thyroid disease (< 0.4 or > 4.0 mIU/L); this will be determined by review of medical records and/or physician clearance
- Have not experienced a weight reduction >= 10% within 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
- Do not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC)
- PROSTATE CANCER COHORT:
- Men > 18 diagnosed with prostate cancer for which antiandrogen therapy (ADT) (castration therapy) is being prescribed for at least 16 weeks; castration may be achieved surgically or using gonadotrophin releasing hormone (LHRH) agonists (i.e. leuprolide, goserelin, etc.) or LHRH antagonists (i.e. degarelix)
- Additional ADT agents may be concurrently administered (abiraterone, bicalutamide, enzalutamide, etc.)
- Men must be obese (BMI > 25) and sedentary (< 60 minutes of structured exercise per week)
Who cannot join
- Patients with metastatic disease (BREAST ONLY)
- Have not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis; a washout period of a minimum of 6 weeks is required from the last anti-cancer treatment received except hormonal therapy
- Patients with a history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise must be evaluated by their physician to assess if they are suitable to proceed on study
- Are planning reconstructive surgery with flap repair during trial and follow-up period
- Are unable to travel to the exercise facility at USC
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on metabolic dysregulation.
SECONDARY OBJECTIVES:
- To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
- 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.
- Conditions
- Cancer Survivor, No Evidence of Disease, Obesity, Overweight, Prostate Carcinoma, Sedentary Lifestyle
- Being tested
- Exercise Intervention, Laboratory Biomarker Analysis, Polar heart rate monitor, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Obesity, Overweight, Prostatic Neoplasms, Sedentary Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo CARE
Exercise InterventionBehavioural
Undergo standard stretching program
Laboratory Biomarker AnalysisOther
Correlative studies
Polar heart rate monitorOther
Also called Monitor
Receive Polar heart rate monitor
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Polar heart rate monitor; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance
Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to week 34
Change in metabolic syndrome (Triglycerides)
The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.
Measured: Baseline up to week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start17 Aug 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Dieli-Conwright, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284346
- Sponsor's protocol ID
- 0S-17-5
- Other IDs
- NCI-2017-01426, 0S-17-5, P30CA014089
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2017
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT03284346
- Acronym / sponsor ID
- 0S-17-5
- Conditions
- Cancer Survivor, No Evidence of Disease, Obesity, Overweight, Prostate Carcinoma, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on metabolic dysregulation.
SECONDARY OBJECTIVES:
- To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (CARE) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Polar heart rate monitor, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (standard stretching) | Active comparator | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- BREAST CANCER COHORT:
- Women newly diagnosed (stage I-III) breast cancer
- Are overweight or obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 25 kg/m^2 (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 completed cancer-related treatment within the past 3 years
Key exclusion criteria (5 listed)
- Patients with metastatic disease (BREAST ONLY)
- Have not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis; a washout period of a minimum of 6 weeks is required from the last anti-cancer treatment received except hormonal therapy
- Patients with a history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise must be evaluated by their physician to assess if they are suitable to proceed on study
- Are planning reconstructive surgery with flap repair during trial and follow-up period
- Are unable to travel to the exercise facility at USC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionUndergo CARE | Behavioural | Arm I (CARE) |
| Exercise InterventionUndergo standard stretching program | Behavioural | Arm II (standard stretching) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (CARE), Arm II (standard stretching) |
| Polar heart rate monitorAlso: MonitorReceive Polar heart rate monitor | Other | Arm I (CARE) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (CARE), Arm II (standard stretching) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (CARE), Arm II (standard stretching) |
Primary outcome
Change in insulin resistance
Time frame: Baseline up to week 34
Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin.
Change in metabolic syndrome (Blood Pressure)
Time frame: Baseline up to week 34
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.
Change in metabolic syndrome (Waist Circumference)
Time frame: Baseline up to week 34
A tape measure will be used to obtain waist circumference defined as the distance around the waist using the umbilicus as the reference point.
Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
Time frame: Baseline up to week 34
The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34.
Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)
Time frame: Baseline up to week 34
The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.
Change in metabolic syndrome (Triglycerides)
Time frame: Baseline up to week 34
The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.
Results and safety
The study was stopped early (reason given: PI left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Dieli-Conwright, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Polar heart rate monitor in people with Cancer Survivor and No Evidence of Disease, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin resistance (time frame: Baseline up to week 34). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.