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临床试验/NCT03494400
NCT03494400已完成不适用

Effects of Aerobic Training in Treatment for Breast Cancer

Universidade Estadual Paulista Júlio de Mesquita Filho1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
Evaluation of body composition by Bone Densitometry (DEXA) equipment

研究概览

简要总结

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%.

详细描述

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%.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Aerobic Training Presential (Other)

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.

干预措施: Aerobic Training Presential (Other)

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.

干预措施: Aerobic Training Home-based (Other)

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.

干预措施: Aerobic Training Home-based (Other)

结局指标

主要结局

Evaluation of body composition by Bone Densitometry (DEXA) equipment

时间窗: 24 week

Reduction of body mass and of increased fat free mass

次要结局

  • Evaluation inflammatory response by ELISA equipment(24 week)
  • Evaluation of pain by questionnarie BPI.(24 week)
  • Nutritional evaluation by food register(24 week)
  • Evaluation of quality of life by questionnarie EORTC-QLQ-30(24 week)
  • Evaluation of level of physical activity by triaxial accelerometer equipment(24 week)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andréa Dias Reis

Clinical Professor

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (1)

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