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TerminatedNCT03284346Updated Sep 29, 2025

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

An interventional study of Exercise Intervention and Exercise Intervention in Cancer Survivor, No Evidence of Disease and Obesity, sponsored by University of Southern California. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by University of Southern California · Not applicable, Interventional, and Supportive care

Why this study was terminated
PI left
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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 · Other: Laboratory Biomarker Analysis · Other: Polar heart rate monitor · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

  • 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 · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

  • BehavioralExercise Intervention

    Undergo CARE

  • BehavioralExercise Intervention

    Undergo standard stretching program

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPolar heart rate monitor

    Receive Polar heart rate monitor

    Also known as: Monitor

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

05

What researchers measure

Primary outcomes

  1. Change in insulin resistance

    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

  2. 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.

    Time frame: Baseline up to week 34

  3. 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.

    Time frame: Baseline up to week 34

  4. 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.

    Time frame: Baseline up to week 34

  5. Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)

    The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.

    Time frame: Baseline up to week 34

  6. Change in metabolic syndrome (Triglycerides)

    The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.

    Time frame: Baseline up to week 34

06

Study locations

1 site
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
07

Registry details

Key details

Study ID
NCT03284346
Lead sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Aug 17, 2017
Primary completion
Jul 15, 2019
Completion
Jul 15, 2019
Last update
Sep 29, 2025

Study contacts

Christina Dieli-Conwright, Ph.D.
principal investigator · University of Southern California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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