Exercise Program for Early Breast Cancer Survivors

Stage IIIA Breast Cancer Clinical Trial

Official title:

Combined Exercise Program for Early Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140282
• Other study ID #: 1B-12-1
• Secondary ID: NCI-2010-01265
• Status: Completed
• Phase: N/A
• Start date: May 21, 2012
• Est. completion date: October 1, 2018

Study information

• Verified date: June 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 1, 2018
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• management of therapy complications
Assessed within 3 days of baseline testing and at post-trial visit

Behavioral:
• exercise intervention
12 week exercise intervention

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c		At week 16
Primary	Improvement of physical fitness, cardiorespiratory fitness, and muscle strength		At week 16
Primary	Feasibility of a supervised exercise program for cancer survivors		At week 16
Primary	Maintain positive benefits of an exercise intervention		12 weeks post-intervention