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Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03284346
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cancer Survivor No Evidence of Disease Obesity Overweight Prostate Carcinoma Sedentary Lifestyle Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : August 17, 2021


Arm Intervention/treatment
Experimental: Arm I (CARE)
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
Undergo CARE

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Receive Polar heart rate monitor
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (standard stretching)
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
Undergo standard stretching program

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284346


Contacts
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Contact: Christina Dieli-Conwright, Ph.D. 323-442-2180 cdieli@usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Christina Dieli-Conwright, Ph.D.    323-442-2905    cdieli@usc.edu   
Principal Investigator: Christina Dieli-Conwright, Ph.D.         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina Dieli-Conwright, Ph.D. University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03284346     History of Changes
Other Study ID Numbers: 0S-17-5
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 )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Body Weight
Signs and Symptoms