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.

Universidade Estadual Paulista Júlio de Mesquita Filho0 sites83 target enrollmentAugust 2015

ConditionsBreast Cancer Aromatase Inhibitors Postmenopausal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Enrollment: 83
Primary Endpoint: Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

Female

Investigators

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Responsible Party

Principal Investigator

Thais Reis Silva de Paulo

masters degree

Universidade Estadual Paulista Júlio de Mesquita Filho

Eligibility Criteria

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

Exclusion Criteria

•Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

Outcomes

Primary Outcomes

Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT

Time Frame: At baseline, 3, 6 and 9 months timepoint

Secondary Outcomes

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)
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)
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)
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 of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay(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)
Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.(At baseline, 3, 6 and 9 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)
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 triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5(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)
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)