Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2