The Effect of Hand-Foot Exercises on Peripheral Neuropathy in Women With Breast Cancer Receiving Neurotoxic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
研究概览
简要总结
This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes
详细描述
İntroduction: New evaluation and care strategies for symptom control are gaining importance due to the increasing prevalence of cancer, expansion of chemotherapy indications, and the development of new chemotherapeutic agents with side effects such as peripheral neuropathy and pain. In the literature review, although there are studies evaluating the effects of neuropathic pain, neuropathy on quality of life and daily living activities, it was determined that there are a very limited number of studies on reducing chemotherapy-induced neuropathy. Simple, at-home exercises to prevent neuropathy can be done daily in a short period of time and do not require special equipment. These exercises may serve as an alternative therapy to improve quality of life by reducing pain in people with neuropathy.
Purpose: This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes.
Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 84 women with breast cancer receiving chemotherapy in the chemotherapy unit of a training and research hospital. Research data will be collected using the Introductory Information Form, Visual Analog Questionnaire (VAS), National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) -Peripheral Neuropathy, EORTC QLQ-CIPN 20. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. Data will be collected in two time periods: the week of starting exercise (T1) and the 8th week after exercise (T2).
Conclusion: It is thought that home-based, simple exercise practices will reduce neuropathy symptoms and improve the quality of life in women with breast cancer receiving neurotoxic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •The age of 18-80 years
- •Clinical diagnosis of breast cancer
- •Must be able to read and speak Turkish
- •Must be the first time the taxane group receives chemotherapy
- •Must be have at least grade 1 neuropathy according to CTCAE
- •Must agree to participate in the study
排除标准
- •Presence of peripheral neuropathy conditions not caused by chemotherapy [tumor compression, nutritional disorders, infections, neurological diseases such as stroke, diabetes, etc.]
- •Skin infection, scar tissue, inflammation, or cuts on the hands or feet
- •Neuropsychiatric disease
研究组 & 干预措施
exercise with massage ball
The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the massage ball group will be given a massage ball to be used in exercises.
干预措施: Hand and foot exercise (Other)
exercise with stress ball
The exercise group will participate in home-based hand and foot exercises for 8 weeks. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. The exercises, which will last for 8 weeks, will be performed 3 times a day and at least 3 times a week. A detailed exercise brochure will be given to the exercise group. Patients in the stress ball group will be given a stress ball to be used in exercises
干预措施: Hand and foot exercise (Other)
control
No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied.
结局指标
主要结局
National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0(NCI-CTCAE v5.0):
时间窗: 8 week
NCI-CTCAE v.5.0 publishes standardized definitions for known adverse events and defines the severity of organ toxicities for patients receiving cancer treatment. In NCI-CTCAE, the severity of chemotherapy-related peripheral neuropathy is divided into two: motor and sensory peripheral neuropathy, and the severity of complaints that interfere with patients' daily life and personal care is questioned.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ- CIPN 20)
时间窗: 8 week
It reveals the effects of chemotherapy-related peripheral neuropathy symptoms and the functional limitations caused by these symptoms on patients. The scale includes sensory (tingling, numbness, pain, unsteadiness when walking or standing, distinguishing temperature and hearing), motor (cramps, writing, grasping small objects, weakness) and autonomic (dizziness after changing position, vision, erectile dysfunction). It has 3 subscales: The 20 items in the scale are Likert type and the answers are evaluated by giving 1 point at all, 2 a little bit, 3 points a lot, 4 points a lot. High scores from these sections indicate more symptoms and problems, and low scores indicate fewer symptoms and problems.
Visual Analog Scale (VAS)
时间窗: 8 week
Visual Analog Scale (VAS) pain score was evaluated as "no pain" (score = 0) and "worst pain" (score = 10).
次要结局
未报告次要终点