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

This study is currently recruiting participants.
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
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

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 April 16, 2014