Clinical trial NCT02804308: Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Aromatase Inhibitors
Postmenopausal
Keywords: Combined Training
Breast Cancer
Body Composition
Postmenopausal Women
Aromatase Inhibitors
Quality of life
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 83
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
timeFrame: At baseline, 3, 6 and 9 months timepoint
Secondary outcomes:
measure: Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie).
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: 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.
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5.
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: The perception of pain is measured by Pain Brief Questionnaire (PBQ
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: VO2max by test of submaximal effort
timeFrame: At baseline, 3, 6 and 9 months timepoint
measure: Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry).
timeFrame: At baseline, 3 and 6 months timepoint
measure: Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL).
timeFrame: At baseline, 3 and 6 months timepoint
measure: 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
timeFrame: At baseline, 3 and 6 months timepoint
measure: Self reported Drug consumption questionnaire
timeFrame: At baseline, 3, 6 and 9 months timepoint
Other outcomes:
Locations:
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Ismael F Freitas Junior, Doctor
role: STUDY_DIRECTOR
References:
citation: Felipe J, Viezel J, Reis AD, da Costa Barros EA, de Paulo TRS, Neves LM, Junior IFF. Relationship of different intensities of physical activity and quality of life in postmenopausal women. Health Qual Life Outcomes. 2020 May 6;18(1):123. doi: 10.1186/s12955-020-01377-1.