Trial record 1 of 1 for:    NCT01140282
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Exercise Program for Early Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01140282
First received: June 4, 2010
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: management of therapy complications
Behavioral: exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Combined Exercise Program for Early Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Improvement of physical fitness, cardiorespiratory fitness, and muscle strength [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
  • Feasibility of a supervised exercise program for cancer survivors [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
  • Maintain positive benefits of an exercise intervention [ Time Frame: 12 weeks post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140282

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90089
Contact: Christina Dieli-Conwright, PhD    323-442-2905    cdieli@usc.edu   
Principal Investigator: Christina Dieli-Conwright, PhD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Christina Dieli-Conwright, Ph.D. University of Southern California
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01140282     History of Changes
Other Study ID Numbers: 1B-12-1, NCI-2010-01265
Study First Received: June 4, 2010
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014