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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804308
• Other study ID #: CAAE46727715100005402
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 16, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aromatase Inhibitors
• Breast Cancer
• Breast Neoplasms
• Postmenopausal

Intervention

Behavioral:
• Combined Training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5		At baseline, 3, 6 and 9 months timepoint	No
Secondary	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	No
Secondary	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	No
Secondary	Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5		At baseline, 3, 6 and 9 months timepoint	No
Secondary	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	No
Secondary	Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.		At baseline, 3, 6 and 9 months timepoint	No
Secondary	The perception of pain is measured by Pain Brief Questionnaire (PBQ		At baseline, 3, 6 and 9 months timepoint	No
Secondary	VO2max by test of submaximal effort		At baseline, 3, 6 and 9 months timepoint	No
Secondary	Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry).		At baseline, 3 and 6 months timepoint	No
Secondary	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	No
Secondary	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	No
Secondary	Self reported Drug consumption questionnaire		At baseline, 3, 6 and 9 months timepoint	No