Clinical trial NCT03708055: Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors
Official title: Prevention of Frailty in Breast Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Cancer Survivor
Overweight
Postmenopausal
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-10-16
Enrollment: 27
Sex: ALL
Minimum age (years): 37
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reproducibility of muscle activation by subcutaneous fat mass measures.
timeFrame: Up to 9 years
measure: Amount of lean muscle as determined by using both appendicular lean mass/height2 method and the residuals model from the Health ABC Study.
timeFrame: 8 weeks
measure: Reproducibility of signal attenuation using electromyography (EMG)
timeFrame: Up two weeks
measure: Level of strength as measured by 8-12 repetition maximum (RM) and by hand grip dynamometer.
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
measure: Measure changes in biomarkers, i.e. insulin resistance, inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin, IGF-1, IGFBP-3 and others).
timeFrame: Up to 8 weeks
measure: Quantitative and qualitative analysis of DNA.
timeFrame: Up to 8 weeks
Locations:
city: Tucson
country: United States
facility: The University of Arizona Medical Center-University Campus
state: Arizona
Study officials:
affiliation: The University of Arizona Medical Center-University Campus
name: Jennifer Bea
role: PRINCIPAL_INVESTIGATOR
References: