Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer

Study Overview
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Brief Summary
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Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.

Official Title
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Effectiveness of Physical Training on Body Composition, Physical Activity Level and Quality of Life of Postmenopausal Women Undergoing Treatment for Breast Cancer With Aromatase Inhibitors: The Randomized Clinical Trial.

Conditions
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Breast Cancer, Aromatase Inhibitors, Postmenopausal

Intervention / Treatment
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* Behavioral: Combined Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal, defined by the absence of periods for the past 12 months; Breast cancer diagnosis stages 1 to 3; The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors No abnormalities on screening physical or any health problems that contraindicate study participation; No contraindications for treadmill testing or entry into a training program, including any of the following: Myocardial infarction within the past 6 months Pulmonary edema Myocarditis Pericarditis Unstable angina Pulmonary embolism or deep vein thrombosis Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg) Uncontrolled arrhythmia No significant mental illness Have medical certificate to perform exercise testing and participate in combined training Able to answer Questionnaires No concurrent participation in any other organized exercise program; Live in Presidente Prudente Sign the consent form and formal clarification for participation in the study. Exclusion Criteria: Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group Control with breast cancer and without breast cancer<br>Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months | |
| Experimental: Combined Training with breast cancer and without breast cancer<br>Combined Training: 36 weeks duration, 3 times a week on nonconsecutive days. The combined training program lasts 70 minutes per session, with 40 minutes of resistance training and 30 minutes of aerobic training. | Behavioral: Combined Training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT |  | At baseline, 3, 6 and 9 months timepoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie). |  | At baseline, 3, 6 and 9 months timepoint | 
| Bone mineral density (total, spine and femur) in these participants by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT. |  | At baseline, 3, 6 and 9 months timepoint | 
| Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 |  | At baseline, 3, 6 and 9 months timepoint | 
| Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 |  | At baseline, 3, 6 and 9 months timepoint | 
| Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5. |  | At baseline, 3, 6 and 9 months timepoint | 
| Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 |  | At baseline, 3, 6 and 9 months timepoint | 
| Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay |  | At baseline, 3, 6 and 9 months timepoint | 
| Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X. |  | At baseline, 3, 6 and 9 months timepoint | 
| The perception of pain is measured by Pain Brief Questionnaire (PBQ |  | At baseline, 3, 6 and 9 months timepoint | 
| VO2max by test of submaximal effort |  | At baseline, 3, 6 and 9 months timepoint | 
| Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry). |  | At baseline, 3 and 6 months timepoint | 
| Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL). |  | At baseline, 3 and 6 months timepoint | 
| Use time of aromatase inhibitor and the response to combined training in the variables of body composition and level of physical activity by bone densitometry (GE Lunar - DPX-NT) and accelerometer motion sensor type triaxial Actigraph brand, mode GT3X |  | At baseline, 3 and 6 months timepoint | 
| Self reported Drug consumption questionnaire |  | At baseline, 3, 6 and 9 months timepoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined Training, Breast Cancer, Body Composition, Postmenopausal Women, Aromatase Inhibitors, Quality of life