Effect of Hilotherapy on Quality of Life and Comfort Level in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Taxan-induced peripheric neuropathy score
研究概览
简要总结
In this randomized controlled study, it was aimed to determine the effect of hilotherapy on quality of life and comfort level in the management of symptoms related to taxane-associated peripheral neuropathy in patients with breast cancer.
- The experimental and control group patients will answer the survey questions according to the data collection forms before the first chemotherapy course (To) and will undergo physical examinations by the researcher.
- In the experimental group, the Hilotherapy device will be connected and initiated 30 min before the chemotherap.
- The device will continue to cool for another 60 minutes when the chemotherapy ends.
- Both groups will continue to receive chemotherapy courses at the intervals determined as planned.
- Hilotherapy will be applied to the experimental group patients during each course according to the study protocol.
- For both groups, participants will answer the questions according to the data collection forms and will undergo physical examinations by the researcher after the 4th chemotherapy course (T1), 8th chemotherapy course (T2), 12th chemotherapy course (T3) and 4 weeks after the end of chemotherapy (T4).
详细描述
Hilotherapy Device Usage
- 30 minutes before chemotherapy, disposable cellulose covers are placed on the patient's clean hands and feet (for hygiene and to prevent contamination)
- The device is set to 12°C for hands and 14°C for feet.
- Sensors are monitored during chemotherapy.
- The hylotherapy application is continued for another 60 minutes after the end of the chemotherapy course.
- At the end of the period, the sleeves and disposable covers are removed.
Data Collection Tools of the Study
- Introductory Information Form (designed by the researchers)
- "Other Methods Used by the Patient to Prevent Peripheral Neuropathy" Form
- Hilotherapy Application Data Form
- LANSS Pain Scale
- European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
- European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Associated Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)
- General Comfort Scale-Short Form
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a primary breast cancer diagnosis
- •Having received chemotherapy containing taxane compounds due to breast cancer
- •Not having been previously diagnosed with peripheral neuropathy
排除标准
- •Presence of distant metastasis
- •History of psychiatric disorder
- •Diagnosed diseases such as diabetes mellitus, autoimmune disease, megaloblastic anemia, cervical/spinal disc herniation, Raynaud's
- •Active lesions on hands or feet
- •Bleeding/clotting disorder
- •Extremity amputation
- •Any problem that prevents cognitive, emotional and verbal communication
结局指标
主要结局
Taxan-induced peripheric neuropathy score
时间窗: Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo)
Taxan-induced peripheric neuropathy score measured by "European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Related Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)" The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) is a specific tool for determining TIPN symptoms. This patient-reported questionnaire comprises 20 items that can be divided into 3 subscales (sensory-9 items, motor-8 items, and autonomic-2 items. Item 39 is not included in any subscale and is analyzed separately as a single item). Responses follow a 4-point Likert scale: 1. = "Not at all" 2. = "A little" 3. = "Quite a bit" 4. = "Very much" Interpretation Higher total scores (closer to 100) = More severe neuropathy symptoms Lower total scores (closer to 0) = Fewer/milder symptoms
次要结局
未报告次要终点
研究者
Nuran Ayşen Pamir Aksoy
Assist. Prof.
Acibadem University