NCT03494400: ATTBC

Aerobic Training in Treatment for Breast Cancer

Completed NA Last updated 30 April 2021

What this trial tests

NA trial testing Aerobic Training Presential in Cancer of Breast in 6 participants. Completed in 30 November 2020.

Timeline

1 July 2018

Primary endpoint
23 June 2019

30 November 2020

Quick facts

Lead sponsor	Universidade Estadual Paulista Júlio de Mesquita Filho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	6
Start date	1 July 2018
Primary completion	23 June 2019
Estimated completion	30 November 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Aerobic Training Presential
• Aerobic Training Home-based

Conditions studied

• Cancer of Breast — all drugs for Cancer of Breast →
• Healthy — all drugs for Healthy →

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho — full company profile →

Who can join

18 and older, female only, with Cancer of Breast or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of home-based aerobic training combined with food orientation on food consumption, daily physical activity and cardiorespiratory fitness among breast cancer survivors: six-month clinical trial.
   Reis AD, Lima LS, Barros ÊADC, Bertoli J, et al · · 2021 · cited 1× · PMID 33978132 · DOI 10.1590/1516-3180.2020.0658.28012021