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

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Aromatase Inhibitors; Postmenopausal
• Intervention / Treatment: Behavioral: Combined Training

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Investigators: Study Director: Ismael F Freitas Junior, Doctor, UPECLIN HC FM Botucatu Unesp

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer; Quality of life; Body Composition; Combined Training; Postmenopausal Women; Aromatase Inhibitors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CAAE46727715100005402