Arm Function in Breast Cancer Survivors: Is There a Decrease in Maximal Capacity and Oxygen Utilization?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Arm ergometer test
研究概览
简要总结
Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Survival can be increased with early diagnosis and more effective treatment methods. However, a wide range of treatment-related complications are observed during and/or after breast cancer treatment. Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal components. Oxygen consumption in cancer patients may be adversely affected by aging, deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
详细描述
In recent years, thanks to the increasing treatment possibilities with the developing technology, the majority of patients show good functional recovery after breast cancer. However, it has been reported that the treatments negatively affect the functional capacity of the upper extremities, daily life, work and social activities and reduce the quality of life. It has also been reported that breast cancer-related lymphedema (BCRL) may both cause and exacerbate treatment-related complications such as decreased functional capacity of the upper extremities and worsened quality of life after breast cancer treatments. In addition, it has been found that lymphedema decreases the muscle strength and range of motion of the limb in which it develops and causes an increase in symptoms such as pain, fatigue and discomfort. These complications caused by lymphedema lead to decreased functional level of the upper extremity, activity limitations and decreased quality of life. Cardiovascular health is negatively affected after breast cancer. Decreased cardiorespiratory performance also has direct consequences on daily task performance and therefore quality of life is negatively affected.
The gold standard method of measuring cardiorespiratory exercise capacity is cardiopulmonary exercise testing (CPET). This method determines the causes of limitation during exercise and gives maximal oxygen consumption (VO2max) as a measure of maximum performance. In cancer patients, the oxygen system may be adversely affected by chemotherapy. Effects of chemotherapeutic agents on respiratory, cardiac, blood, vascular or skeletal muscle functions have been observed, potentially contributing to impaired cardiorespiratory fitness. Cardiorespiratory function is not routinely measured at any stage of breast cancer treatment and CPET is rarely used in clinical settings. Although low VO2max measurements have been observed in intervention studies during breast cancer survivorship and these studies were conducted without the use of an arm ergometer, to our knowledge, there is very limited information on the impact of cancer treatment on cardiorespiratory fitness using gold standard testing methods.
Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast Cancer Group:
- •Being between 18-65 years of age,
- •Volunteering to participate in the research,
- •Stage I-III breast cancer,
- •At least 15 months after breast cancer surgery,
- •Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
- •No lymphedema
- •No problems in reading and/or understanding the scales and being able to cooperate with the tests,
- •Healthy group:
- •Age between 18-65 years,
- •Volunteering to participate in the research,
- •No problems in reading and/or understanding the scales and being able to cooperate with the tests.
排除标准
- •Breast Cancer Group:
- •Presence of active infection,
- •Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
- •Having a neurological disease or other clinical diagnosis that may affect cognitive status.
- •Healthy group:
- •Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
- •Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests
研究组 & 干预措施
Breast Cancer Group
Inclusion criteria for BCS were as follows: an age between 18 and 65 years; diagnosis of stage I-III BC; individuals with unilateral BC; ≥ 15 months must have passed since BC surgery; participants must have completed active cancer treatment (CT and/or RT) ≥ 6 months prior to joining the study; absence of BCRL; ability to read and understand questionnaires; and ability to cooperate with the assessments. Exclusion criteria for BCS included the presence of active infection, presence of BCRL; musculoskeletal or neurological conditions affecting exercise performance, symptomatic cardiovascular disease, neurological disorders, or any condition that could impair cognitive function.
干预措施: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak) (Diagnostic Test)
Breast Cancer Group
Inclusion criteria for BCS were as follows: an age between 18 and 65 years; diagnosis of stage I-III BC; individuals with unilateral BC; ≥ 15 months must have passed since BC surgery; participants must have completed active cancer treatment (CT and/or RT) ≥ 6 months prior to joining the study; absence of BCRL; ability to read and understand questionnaires; and ability to cooperate with the assessments. Exclusion criteria for BCS included the presence of active infection, presence of BCRL; musculoskeletal or neurological conditions affecting exercise performance, symptomatic cardiovascular disease, neurological disorders, or any condition that could impair cognitive function.
干预措施: Muscle oxygenation (Diagnostic Test)
Control Group
Inclusion criteria for healthy controls were an age between 18 and 65 years, the willingness to participate, the ability to read and understand questionnaires, and the ability to cooperate with the assessments. Exclusion criteria for healthy controls were the presence of orthopedic or neuromuscular conditions, chronic diseases, psychiatric or other mental conditions that could interfere with exercise testing.
干预措施: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak) (Diagnostic Test)
Control Group
Inclusion criteria for healthy controls were an age between 18 and 65 years, the willingness to participate, the ability to read and understand questionnaires, and the ability to cooperate with the assessments. Exclusion criteria for healthy controls were the presence of orthopedic or neuromuscular conditions, chronic diseases, psychiatric or other mental conditions that could interfere with exercise testing.
干预措施: Muscle oxygenation (Diagnostic Test)
结局指标
主要结局
Arm ergometer test
时间窗: One Year
estimated Oxygen Consumption (VO2max)
次要结局
- Upper Extremity Oxidative Muscle Metabolism(One Year)
- Evaluation of Quality of Life(One Year)
- anthropometric measurements(One Year)
- Peripheral Muscle Strength(One Year)
- Fatigue Measurement(One Year)
- Upper extremity muscle endurance(one year)
研究者
Ebru Calik
Associate Professor
Hacettepe University