Healthy Clinical Trial
— ATTBCOfficial title:
Effects of Aerobic Training in Treatment for Breast Cancer
Verified date | April 2021 |
Source | Universidade Estadual Paulista Júlio de Mesquita Filho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 6 |
Est. completion date | November 30, 2020 |
Est. primary completion date | June 23, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista Júlio de Mesquita Filho | Presidente Prudente | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual Paulista Júlio de Mesquita Filho |
Brazil,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of body composition by Bone Densitometry (DEXA) equipment | Reduction of body mass and of increased fat free mass | 24 week | |
Secondary | Evaluation of quality of life by questionnarie EORTC-QLQ-30 | Increased of quality of life global | 24 week | |
Secondary | Evaluation inflammatory response by ELISA equipment | Reduction of interleukin- IL 6 | 24 week | |
Secondary | Evaluation of pain by questionnarie BPI. | Reduction of pain intensity to increased of functional capacity | 24 week | |
Secondary | Evaluation of level of physical activity by triaxial accelerometer equipment | Increased of level of physical activity | 24 week | |
Secondary | Nutritional evaluation by food register | Increased of quality of food | 24 week |
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