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

NCT03284346 | Terminated DMC

• 3 other identifiers: 0S-17-5NCI-2017-01426P30CA014089
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Change in metabolic syndrome (Triglycerides)

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

  Baseline up to week 34

Study Arms (2)

Arm I (CARE)

EXPERIMENTAL

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

Arm II (standard stretching)

ACTIVE COMPARATOR

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

Exercise Intervention BEHAVIORAL

Undergo CARE

Arm I (CARE)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (CARE); Arm II (standard stretching)

Polar heart rate monitor OTHER

Receive Polar heart rate monitor

Also known as: Monitor

Arm I (CARE)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (CARE); Arm II (standard stretching)

Questionnaire Administration OTHER

Ancillary studies

Arm I (CARE); Arm II (standard stretching)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Prostatic Neoplasms; Sedentary Behavior; Breast Neoplasms

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina Dieli-Conwright, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: September 15, 2017
• Study Start: August 17, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)