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

Primary Purpose

Cancer Survivor, No Evidence of Disease, Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Exercise Intervention
Laboratory Biomarker Analysis
Monitoring Device
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (CARE)

Arm II (standard stretching)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in insulin resistance
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)
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)
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)
The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 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.
Change in metabolic syndrome (Triglycerides)
The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2017
Last Updated
May 9, 2020
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03284346
Brief Title
Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
Official Title
Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
PI left
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (CARE)
Arm Type
Experimental
Arm Description
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 Title
Arm II (standard stretching)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo CARE
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo standard stretching program
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Device
Intervention Name(s)
Monitoring Device
Other Intervention Name(s)
Monitor
Intervention Description
Receive Polar heart rate monitor
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in insulin resistance
Description
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
Title
Change in metabolic syndrome (Blood Pressure)
Description
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
Title
Change in metabolic syndrome (Waist Circumference)
Description
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
Title
Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
Description
The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34.
Time Frame
Baseline up to week 34
Title
Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)
Description
The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.
Time Frame
Baseline up to week 34
Title
Change in metabolic syndrome (Triglycerides)
Description
The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.
Time Frame
Baseline up to week 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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