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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

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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 CenterLos Angeles, California  90089