Aerobic Training in Treatment for Breast Cancer

NCT03494400 | Completed

• 1 other identifier: State University of São Paulo
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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%.

Conditions

Cancer of Breast; Healthy

Keywords

Breast cancer; Physical exercise; Body mass

Outcome Measures

Primary Outcomes (1)

• Evaluation of body composition by Bone Densitometry (DEXA) equipment

  Reduction of body mass and of increased fat free mass

  24 week

Secondary Outcomes (5)

• Evaluation of quality of life by questionnarie EORTC-QLQ-30

  24 week

• Evaluation inflammatory response by ELISA equipment

  24 week

• Evaluation of pain by questionnarie BPI.

  24 week

• Evaluation of level of physical activity by triaxial accelerometer equipment

  24 week

• Nutritional evaluation by food register

  24 week

Study Arms (4)

Presential Aerobic Training with Hormone Therapy

EXPERIMENTAL

A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training.

Other: Aerobic Training Presential

Presential Aerobic Training without Breast Cancer

ACTIVE COMPARATOR

A group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training.

Other: Aerobic Training Presential

Home-based Aerobic Training with Hormone Therapy

EXPERIMENTAL

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

Home-based Aerobic Training without Breast Cancer

ACTIVE COMPARATOR

A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based.

Other: Aerobic Training Home-based

Interventions

Aerobic Training Presential OTHER

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.

Also known as: Physical exercise Presential

Presential Aerobic Training with Hormone Therapy; Presential Aerobic Training without Breast Cancer

Aerobic Training Home-based OTHER

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.

Also known as: Physical exercise Home-based

Home-based Aerobic Training with Hormone Therapy; Home-based Aerobic Training without Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Do not use Tamoxifen or Aromatase Inhibitor;
• Not being diagnosed with any type of cancer.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060-560, Brazil

Location

Related Publications (5)

• 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.

  PMID: 24829866 BACKGROUND

• 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.

  PMID: 25834616 BACKGROUND

• 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.

  PMID: 28086943 BACKGROUND

• 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.

  PMID: 26068412 BACKGROUND

• 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.

  PMID: 26050790 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• ISMAEL F FREITAS JUNIOR

  Universidade Estadual Paulista Júlio de Mesquita Filho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 11, 2018
• Study Start: July 1, 2018
• Primary Completion: June 23, 2019
• Study Completion: November 30, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)