Aerobic Training in Treatment for Breast Cancer (ATTBC)

Effects of Aerobic Training in Treatment for Breast Cancer

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%.

Study Overview

• Status: Completed
• Conditions: Healthy; Cancer of Breast
• Intervention / Treatment: Other: Aerobic Training Presential; Other: Aerobic Training Home-based

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%.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Presidente Prudente, São Paulo, Brazil, 19060-560
      • Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista Júlio de Mesquita Filho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Presential Aerobic Training with Hormone Therapy; A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training.	Other: Aerobic Training Presential; 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.; Other Names: Physical exercise Presential
Active Comparator: Presential Aerobic Training without Breast Cancer; A group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training.	Other: Aerobic Training Presential; 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.; Other Names: Physical exercise Presential
Experimental: Home-based Aerobic Training with Hormone Therapy; 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; 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.; Other Names: Physical exercise Home-based
Active Comparator: Home-based Aerobic Training without Breast Cancer; A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based.	Other: Aerobic Training Home-based; 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.; 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

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Investigators: Study Director: ISMAEL F FREITAS JUNIOR, Universidade Estadual Paulista Julio de Mesquita Filho

Publications and helpful links

General Publications

• Battaglini CL, Mills RC, Phillips BL, Lee JT, Story CE, Nascimento MG, Hackney AC. Twenty-five years of research on the effects of exercise training in breast cancer survivors: A systematic review of the literature. World J Clin Oncol. 2014 May 10;5(2):177-90. doi: 10.5306/wjco.v5.i2.177.
• Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.
• Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1.
• Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.
• Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 23, 2019
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; Physical exercise; Body mass
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: State University of São Paulo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No