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

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho (Other)

Overall Status

Completed

CT.gov ID

NCT02804308

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Aromatase Inhibitors Postmenopausal	Behavioral: Combined Training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group Control with breast cancer and without breast cancer Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months
Experimental: Combined Training with breast cancer and without breast cancer 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

Arm

Intervention/Treatment

No Intervention: Group Control with breast cancer and without breast cancer

Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months

Experimental: Combined Training with breast cancer and without breast cancer

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.