Aerobic Training in Treatment for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer. Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer. Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.

Detailed Description
-----------------
Introduction. Breast cancer is one of the leading causes of morbidity and mortality in the world.Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes (lipid and low grade systemic inflammation) and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer. Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer. Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. Where participants will be distributed in six groups submitted to intervention with aerobic training: Tamoxifen group with face-to-face training (GTP); Aromatase Inhibitor Group with face-to-face training (GIP); Tamoxifen training group by distance monitoring (GTA); Training group Aromatase inhibitor by distance monitoring (GIA); Group without training with cancer (GC) and Group training face-to-face without cancer (GTSC). A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers will analyze: biomarkers (Tumor Necrosis Factor-Alpha (TNFα), (LDL), High Density Lipoprotein (HDL), and Very Low Density Lipoprotein (VLDL), as well as in the lipid profile (triglycerides, total cholesterol and low density lipoprotein (LDL) fractions) ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.

Official Title
-----------------
Effects of Aerobic Training in Treatment for Breast Cancer

Conditions
-----------------
Cancer of Breast, Healthy

Intervention / Treatment
-----------------
* Other: Aerobic Training Presential
* Other: Aerobic Training Home-based


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast cancer; Perform Tamoxifen or Aromatase Inhibitor Treatment; Being in stages 1 to 3 of breast cancer; Do not present physical limitations or any health problem that prevents the performance of the evaluations and the training; Have a medical certificate to perform the ergometric test and participate in physical training; Not practicing physical training in the last six months; Sign the Term of Free Consent and Clarification. Inclusion Criteria for the group without cancer Do not use Tamoxifen or Aromatase Inhibitor; Not being diagnosed with any type of cancer. Exclusion Criteria: Accumulate three consecutive absences or four non-consecutive absences in presential training during the month; Failure to attend the scheduled bi-weekly activities in the case of the home-based training group; Do not send information about the activities carried out in the case of the home-based group

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presential Aerobic Training with Hormone Therapy<br>A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training. | Other: Aerobic Training Presential<br>* The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up.<br>* Other names: Physical exercise Presential;|
| Active Comparator: Presential Aerobic Training without Breast Cancer<br>A group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training. | Other: Aerobic Training Presential<br>* The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up.<br>* Other names: Physical exercise Presential;|
| Experimental: Home-based Aerobic Training with Hormone Therapy<br>A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform home-based aerobic training. | Other: Aerobic Training Home-based<br>* The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up.<br>* Other names: Physical exercise Home-based;|
| Active Comparator: Home-based Aerobic Training without Breast Cancer<br>A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based. | Other: Aerobic Training Home-based<br>* The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up.<br>* Other names: Physical exercise Home-based;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of body composition by Bone Densitometry (DEXA) equipment | Reduction of body mass and of increased fat free mass | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life by questionnarie EORTC-QLQ-30 | Increased of quality of life global | 24 week | 
| Evaluation inflammatory response by ELISA equipment | Reduction of interleukin- IL 6 | 24 week | 
| Evaluation of pain by questionnarie BPI. | Reduction of pain intensity to increased of functional capacity | 24 week | 
| Evaluation of level of physical activity by triaxial accelerometer equipment | Increased of level of physical activity | 24 week | 
| Nutritional evaluation by food register | Increased of quality of food | 24 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Physical exercise, Body mass