Pre-habilitation Program for Women Indicated to Breast Cancer Surgical Treatment.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Changes in functional capacity and muscle strength - dynamometry assessment using handgrip strength
研究概览
简要总结
The National Cancer Institute estimated 625 thousand new cases of cancer (excluding cases of non-melanoma skin cancer) in Brazil for each year between 2020-2022. In 2018, there were 2.1 million new cases of breast cancer in the world, being the first in the ranking of cancers in women. Practices in healthy eating and exercise can protect and / or decrease the risk of breast cancer and improve treatment results. Breast cancer treatments cause cardiovascular changes due to age-related factors, pre-existing chronic diseases and comorbidities such as obesity, smoking and dyslipidemia. Obesity is associated with the development of several types of cancer, including breast cancer. Therapies for breast cancer have a strong association with impaired cardiac function, ranging from permanent, transient cardiotoxic effects and changes in lipid metabolism. In addition to the cardiotoxic effects, the pathophysiology of cancer and treatment favor the appearance of muscle changes, such as sarcopenia. There is sufficient evidence to support that exercise improves fitness before, during and after the completion of cancer treatment. Pre-qualification in cancer treatment is an opportunity to increase physiological reserves before neoadjuvant therapies or surgery, with the intention of improving results and accelerating recovery. It can be composed of physical exercises, nutritional interventions, and psychosocial. Excess weight or depletion are factors that negatively influence surgical and cancer outcomes. In view of the evidence, the aim of this project is to evaluate the effectiveness of physical exercise in a surgical pre-habilitation program for women diagnosed with breast cancer undergoing cancer treatment with a curative therapeutic proposal at the National Cancer Institute in Rio de Janeiro. This is a randomized clinical trial, where patients will be randomly allocated to the Intervention Group and the Control Group. The patients in the intervention group will be instructed to practice physical exercises at home until the date of surgery and those in the control group will only be instructed to maintain their usual activities. All patients will be guided individually by a nutritionist with a view to a healthier nutritional status and control of comorbidities.
详细描述
INTRODUCTION The National Cancer Institute estimated 625 thousand new cases of cancer (excluding non-melanoma skin cancer cases) in Brazil for each year between 2020-2022, In 2018, 2.1 million new cases of breast cancer occurred in the world , equivalent to 11.6% of all estimated cancers, being the first in the ranking of cancers for females. Among the environmental and behavioral risk factors for breast cancer, alcohol consumption, excess body weight and physical inactivity, are some of the modifiable factors. Obesity, as a risk factor for breast cancer, makes many women obese when diagnosed and when starting treatment. Adhering to healthy eating and exercise can protect and / or decrease the risk of breast cancer, in addition to improving results during and after the active phase of treatment.
After the diagnosis of the disease and evaluation of its stage, the treatment can be defined as neoadjuvant or adjuvant; systemic or regional locus. Breast cancer treatments cause cardiovascular dysfunctions, which are due to age-related factors, pre-existing chronic diseases, comorbidities such as smoking, dyslipidemia and obesity, in addition to cancer treatment.Therapies for breast cancer have a strong association with impaired cardiac function, from transient and reversible changes to permanent dysfunctions, as well as changes in lipid metabolism.
The cardiotoxic effects of cancer treatments can also affect vagal activity and, thus, influence cardiac autonomic balance. In the long run, autonomic imbalance is associated with an increased risk of cardiovascular disease and mortality, and in addition, the autonomic dysfunction that is common in many types of cancer leads to an increase in sympathetic tone and a decrease in cardiac vagal tone. As a way of assessing autonomic activity and vagal response, measures of heart rate variability (HRV) have been adopted. A reduction in parasympathetic modulation and HRV indices was observed in women with breast cancer who underwent chemotherapy, radiotherapy and hormonal therapy after one year of treatment. Physical training, which already has satisfactory results in cancer patients in relation to quality of life related to health, functionality and other aspects, also showed benefits in the autonomic modulation of patients with breast cancer. In non-cancer patients, exercise interventions show improvements in the modulation of autonomic function, minimizing cardiovascular problems and reducing mortality after episodes of myocardial infarction.
In addition to the cardiotoxic effects, cancer treatment favors the appearance of muscle changes. A systematic review with 754 women with breast cancer showed sarcopenia as a risk factor for mortality in 68% of patients. Not only the pathophysiology of cancer, but also drugs used for its treatment contribute to the loss of muscle mass.
Research indicates that physical exercise can mitigate the declines induced by cancer treatment. There is sufficient evidence to support that exercise improves fitness before, during and after treatment is completed. A cardiovascular rehabilitation program based on education and behavioral counseling offers a modification of cardiac risk, increases functional capacity, ensures monitoring of the patient's functional status, improves psychosocial well-being and can reduce recurrent hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher by statistical analysis will be blind, as he will not be participating in the data collection.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of breast cancer and indication for cancer treatment with a curative therapeutic proposal
排除标准
- •having a previous cancer diagnosis
- •staging IV
- •practitioner of physical exercise at least 90 minutes per week
- •not being able to answer the questionnaires
- •be unable to practice unsupervised exercises for any reason, including: dysfunctionss orthopedic, neurological, decompensated cardiorespiratory and severe renal.
结局指标
主要结局
Changes in functional capacity and muscle strength - dynamometry assessment using handgrip strength
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
The handgrip strength will be assessed using the Kratos dynamometer (model ZM - manual, Brazil). During the execution of the grasping movement, the patients are positioned seated with the adducted arm parallel to the trunk, shoulder in neutral rotation and elbow flexed at 90 °. Three measurements are made, with a minimum interval of 30 seconds between them, and the highest value obtained is considered.
Changes in functional and cardiopulmonary capacity - evaluation of the 6-minute walk test
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
The six-minute walk test will be performed in a 20-meter flat corridor, with previously demarcated distances, following the recommendations of the American Thoracic Society. Monitoring of blood pressure (BP), heart rate (HR), partial oxygen saturation (SpO2) and BORG effort perception scale will be performed before, during and after the test. For the collection of HR and SpO2 the pulse oximeter G-TECH model LED (MD 300C19) will be used and for blood pressure measurement the sphygmomanometer Heidji.
Changes cardiopulmonary capacity - evaluation of the cardiac autonomic modulation through heart rate variability.
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
It will be evaluated through the collection of HRV. Data will be extracted via Polar V800.
Changes in Sarcopenia - muscle strength and performance assessment using Time Up and Go Test
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
Individuals will be asked to get up from a standard chair, walk to a marker 3 meters away and return the chair, sitting down again. The time spent will be measured with a stopwatch.
Changes in Sarcopenia - muscle strength and performance assessment using SARC-F questionnaire
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
The questionnaire consists of 5 questions for the assessment of muscle strength limitations, the ability to walk, get up from a chair, up and down stairs and experiences with falls, used to assess physical performance in sarcopenia. In 2016, a change in this questionnaire was suggested, in addition to the questions, adding the calf circumference measurement.Such an evaluation will be performed by adopting the measurement of the largest perimeter (maximum measurement in the plane perpendicular to the longitudinal line of the calf) with the patient sitting with the knees and ankles flexed at an angle of ninety degrees and feet 20 cm apart from each other using an inextensible tape ( Sanny®, model TR-4010, Brazil). The measuring tape will be passed along the entire length of the calf in an adjusted manner, but without compressing the skin. The measurements will be recorded in the nearest cm.
Changes in Sarcopenia - Evaluation of the corrected arm muscle area
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
To calculate this measure, the equations proposed by Heymsfield will be used, according to gender, using in the formula the triciptal skin fold.
Changes in functional and cardiopulmonary capacity - evaluation of the 6-minute step test
时间窗: Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.
The six-minute step test will be performed with a step measuring 17 cm in height, 80 cm in width and 30 cm in length, following the same recommendations of the American Thoracic Society to the six-minute walk test. The patient must go up and down the steps for 6 minutes and the evaluator must have at the end of the test the total amount of ups and downs performed. Monitoring of blood pressure (BP), heart rate (HR), partial oxygen saturation (SpO2) and BORG effort perception scale will be performed before, during and after the test. For the collection of HR and SpO2 the pulse oximeter G-TECH model LED (MD 300C19) will be used and for blood pressure measurement the sphygmomanometer Heidji.
次要结局
- Changes in Nutritional Risk(Inclusion and pre-surgical moment)
- Changes in Fatigue(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Changes in Physical activity level(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Changes in Health-related quality of life(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Assessment of adherence to physical exercises(pre-surgical moment)
- Assessment of behavioral change in physical exercise(pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Evaluation of the patients' perception regarding the performance of the exercises(pre-surgical moment)
- Changes in alcohol consumption and smoking(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Changes in anthropometric data through body weight assessment(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)
- Evaluation of anthropometric data by height(Inclusion)
- Changes in anthropometric data through tricipital skin fold assessment(Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.)