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

Obesity Clinical Trial

Official title:

Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03284346
• Other study ID #: 0S-17-5
• Secondary ID: NCI-2017-014260S
• Status: Terminated
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: May 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Survivor
• No Evidence of Disease
• Obesity
• Overweight
• Prostate Carcinoma
• Prostatic Neoplasms
• 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

Intervention

Behavioral:
• Exercise Intervention
Undergo CARE
• Exercise Intervention
Undergo standard stretching program

Other:
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Monitoring Device
Receive Polar heart rate monitor

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in metabolic syndrome (Triglycerides)	The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.	Baseline up to week 34