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Combined Exercise Program for Early Breast Cancer Survivors


N/A
18 Years
N/A
Open (Enrolling)
Female
Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Thank you

Trial Information

Combined Exercise Program for Early Breast Cancer Survivors


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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c

Outcome Time Frame:

At week 16

Safety Issue:

No

Principal Investigator

Christina Dieli-Conwright, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

1B-12-1

NCT ID:

NCT01140282

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • cancer survivor
  • Breast Neoplasms

Name

Location

USC Norris Comprehensive Cancer Center Los Angeles, California  90089