Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Obesity Weight Loss, Postmenopausal Syndrome, Women's Studies
Therapuetic Areas:Endocrinology, Oncology, Reproductive
Healthy:No
Age Range:37 - 65
Updated:10/25/2018
Start Date:July 24, 2008
End Date:April 4, 2017

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Prevention of Frailty in Breast Cancer Survivors: A Pilot Study

This trial studies how well weight bearing exercise works in preventing frailty in stage
I-IIIA breast cancer survivors. Weight bearing exercise, including muscle-strengthening,
aerobic, flexibility, and balance exercises, can decrease fat and increase muscle, which may
lead to reduced frailty.

PRIMARY OBJECTIVES:

I. Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in
a healthy convenience sample/population (N= 10).

II. Demonstrate that measures of muscle activation and signal attenuation by subcutaneous fat
mass can be conducted in a systematic and reproducible fashion in breast cancer survivors
prior to and following weight bearing exercise training.

III. In a cross sectional analysis, describe the level of lean muscle mass, muscle
activation, strength, insulin resistance, inflammatory cytokines and growth factors, and
inter-individual variability in breast cancer survivors prior to training.

IV. Describe the level of lean muscle mass, muscle activation, strength, insulin resistance,
inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin,
IGF-1, IGFBP-3 and others) in breast cancer survivors following weight bearing exercise
training.

V. Evaluate the influence of genetic variability on response to prescribed training in breast
cancer survivors.

OUTLINE:

Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5
days a week for 8 weeks.

Inclusion Criteria:

- Post-menopausal (12 months without menstrual period: naturally, surgically, by hormone
suppression).

- History of early stage breast cancer (stage I, II, IIIa).

- At least 6 months from chemotherapy.

- May be receiving hormonal therapy during the study.

- Currently disease-free, including a negative mammogram within 1 year.

- Body mass index (BMI) between 25 and 40kg/m^2.

- In general good health with no acute or chronic disease that could worsen with weight
bearing exercise.

- Not currently on a prescribed diet nor reporting weight loss of > 10 pounds (lbs) in
previous 3 months.

- Not currently participating in physical activity (PA) independently or a structured
program (performing < 120 min of low-intensity, low-impact exercise per week; and no
weightlifting or similar physical activity).

- Ability to participate in physical activity, not limited by severe disability (e.g.,
severe arthritic conditions); chronic back pain, or history or presence of diseases
for which increased physical activity would not be advised.

- No severe chronic disease, other than breast cancer (e.g., human immunodeficiency
virus/acquired immunodeficiency syndrome [HIV/AIDS], kidney failure, liver failure,
chronic obstructive pulmonary disease, congestive heart failure, Alzheimer?s, unstable
angina, uncontrolled asthma, uncontrolled diabetes, uncontrolled hypertension).

- No implanted cardiac pacemaker, cardiac defibrillator, or other implanted electronic
medical equipment.

- No history of drug or alcohol abuse.

- Able to remain in a lying or sitting position for an extended period (> 30 minutes).

- No history or presence of a significant psychiatric disorder or any other condition
that would interfere with participation in the trial.

- Medical clearance by treating physician.

- Willing to discontinue nonsteroidal antiinflammatory drug (NSAID) use, except Tylenol
and baby aspirin (80mg), 1 week prior to blood draws.

- Willing to maintain body weight during the study.

- Can be reached by telephone.

- Willing to complete consent process and sign informed consent form.
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Tucson, AZ
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