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Exercise Program for Early Breast Cancer Survivors

This study is currently recruiting participants.
Verified April 2017 by University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT01140282
First Posted: June 9, 2010
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
June 4, 2010
June 9, 2010
April 13, 2017
May 21, 2012
May 21, 2018   (Final data collection date for primary outcome measure)
  • Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c [ Time Frame: At week 16 ]
  • Improvement of physical fitness, cardiorespiratory fitness, and muscle strength [ Time Frame: At week 16 ]
  • Feasibility of a supervised exercise program for cancer survivors [ Time Frame: At week 16 ]
  • Maintain positive benefits of an exercise intervention [ Time Frame: 12 weeks post-intervention ]
  • Cardiorespiratory fitness [ Time Frame: At week 14 ]
  • Muscle strength [ Time Frame: At week 14 ]
  • Psychological health [ Time Frame: At week 14 ]
  • Assessment of flexibility as a result of a community-based group exercise program [ Time Frame: At week 14 ]
  • Quality of life [ Time Frame: At week 14 ]
  • Assessment of AI symptoms [ Time Frame: At week 14 ]
  • Joint range of motion [ Time Frame: At week 14 ]
  • Assessment of balance as a result of a community-based group exercise program [ Time Frame: At week 14 ]
Complete list of historical versions of study NCT01140282 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exercise Program for Early Breast Cancer Survivors
Combined Exercise Program for Early Breast Cancer Survivors

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.

PRIMARY OBJECTIVES:

I. 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).

II. 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.

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

IV. 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.

V. 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • 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 Name: quality of life assessment
  • Procedure: management of therapy complications
    Assessed within 3 days of baseline testing and at post-trial visit
    Other Name: complications of therapy, management of
  • Behavioral: exercise intervention
    12 week exercise intervention
  • Active Comparator: Arm I (Control)
    Patients refrain from increasing physical activity levels for 16 weeks.
    Interventions:
    • Other: questionnaire administration
    • Procedure: quality-of-life assessment
    • Procedure: management of therapy complications
  • 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.
    Interventions:
    • Other: questionnaire administration
    • Procedure: quality-of-life assessment
    • Procedure: management of therapy complications
    • Behavioral: exercise intervention
Dieli-Conwright CM, Mortimer JE, Schroeder ET, Courneya K, Demark-Wahnefried W, Buchanan TA, Tripathy D, Bernstein L. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods. BMC Cancer. 2014 Apr 3;14:238. doi: 10.1186/1471-2407-14-238.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 21, 2019
May 21, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Christina Dieli-Conwright, Ph.D. 323-442-2180 cdieli@usc.edu
United States
 
 
NCT01140282
1B-12-1
NCI-2010-01265
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Principal Investigator: Christina Dieli-Conwright, Ph.D. University of Southern California
University of Southern California
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP