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Exercise Program for Early Breast Cancer Survivors

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT01140282
Collaborator
National Cancer Institute (NCI) (NIH)
106
Enrollment
1
Location
2
Arms
76.4
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.

Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
  • Procedure: management of therapy complications
  • Behavioral: exercise intervention
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c).

  2. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength.

  3. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors.

  4. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.

  5. To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.

OUTLINE:

Patients are randomized to 1 of 2 arms.

Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.

Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Combined Exercise Program for Early Breast Cancer Survivors
Actual Study Start Date :
May 21, 2012
Actual Primary Completion Date :
Sep 28, 2017
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (Control)

Patients refrain from increasing physical activity levels for 16 weeks.

Other: questionnaire administration
Administered within 3 days of baseline testing and at post-trial visit

Procedure: quality-of-life assessment
Administered within 3 days of baseline testing and at post-trial visit
Other Names:
  • quality of life assessment

    • Procedure: management of therapy complications
    Assessed within 3 days of baseline testing and at post-trial visit
    Other Names:
  • complications of therapy, management of

    		•
    Experimental: Arm II (Exercise)

    Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.

    Other: questionnaire administration
    Administered within 3 days of baseline testing and at post-trial visit

    Procedure: quality-of-life assessment
    Administered within 3 days of baseline testing and at post-trial visit
    Other Names:
  • quality of life assessment

    • Procedure: management of therapy complications
    Assessed within 3 days of baseline testing and at post-trial visit
    Other Names:
  • complications of therapy, management of

    • Behavioral: exercise intervention
    12 week exercise intervention

    Outcome Measures

    Primary Outcome Measures

    1. Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c [At week 16]

    2. Improvement of physical fitness, cardiorespiratory fitness, and muscle strength [At week 16]

    3. Feasibility of a supervised exercise program for cancer survivors [At week 16]

    4. Maintain positive benefits of an exercise intervention [12 weeks post-intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Newly diagnosed (I-III) with a first primary invasive breast cancer

    • Have undergone a lumpectomy or mastectomy

    • Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion

    • Body mass index (BMI) > 25 kg/m^2 or body fat > 30% (determined by Dr. Dieli-Conwright at baseline visit)

    • Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period

    • Nonsmokers (i.e., not smoking during previous 12 months)

    • Willing to travel to the exercise facility and USC

    • Able to provide physician clearance to participate in exercise program

    • Women of all racial and ethnic backgrounds will be included in the study enrollment process

    Exclusion Criteria:

    • History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease

    • Weight reduction >= 10% within past 6 months

    • Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy)

    • Metastatic disease

    • Planned reconstructive surgery with flap repair during trial and follow-up period

    • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC Norris Comprehensive Cancer Center Los Angeles California United States 90089

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Christina Dieli-Conwright, Ph.D., University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT01140282
    Other Study ID Numbers:
    • 1B-12-1
    • NCI-2010-01265
    First Posted:
    Jun 9, 2010
    Last Update Posted:
    Jun 18, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Southern California
    cancer survivor
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 18, 2019