Exercise Program for Early Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-21

Study Completion Date

2018-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (Control)

Patients refrain from increasing physical activity levels for 16 weeks.

Group Type ACTIVE_COMPARATOR

questionnaire administration

Intervention Type OTHER

Administered within 3 days of baseline testing and at post-trial visit

quality-of-life assessment

Intervention Type PROCEDURE

Administered within 3 days of baseline testing and at post-trial visit

management of therapy complications

Intervention Type PROCEDURE

Assessed within 3 days of baseline testing and at post-trial visit

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.

Group Type EXPERIMENTAL

questionnaire administration

Intervention Type OTHER

Administered within 3 days of baseline testing and at post-trial visit

quality-of-life assessment

Intervention Type PROCEDURE

Administered within 3 days of baseline testing and at post-trial visit

management of therapy complications

Intervention Type PROCEDURE

Assessed within 3 days of baseline testing and at post-trial visit

exercise intervention

Intervention Type BEHAVIORAL

12 week exercise intervention

Interventions

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questionnaire administration

Administered within 3 days of baseline testing and at post-trial visit

Intervention Type OTHER

quality-of-life assessment

Administered within 3 days of baseline testing and at post-trial visit

Intervention Type PROCEDURE

management of therapy complications

Assessed within 3 days of baseline testing and at post-trial visit

Intervention Type PROCEDURE

exercise intervention

12 week exercise intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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quality of life assessment complications of therapy, management of

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No