Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Patient-reported CIPN symptoms
研究概览
简要总结
The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.
详细描述
CIPN is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of CIPN. The nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. In this case we intend to combine therapeutic exercise with BFR to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •HER2+ breast cancer diagnosis
- •On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)
排除标准
- •Previous diagnosis of cancer
- •Cardiac pathology
- •No symptoms or pathology that could be confused with neuropathy or related to diabetes
- •No recommendation from oncologist for therapeutic exercise practice
结局指标
主要结局
Patient-reported CIPN symptoms
时间窗: Change from Baseline to 12 weeks (after intervention)
Symptoms across to sensory, motor and automic domains will be measured using the questionnarie the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased symptom burden.
次要结局
- CIPN severity(Change from Baseline to 12 weeks (after intervention))
- Mood Assessment(Change from Baseline to 12 weeks (after intervention))
- Touch Detection Thresholds(Change from Baseline to 12 weeks (after intervention))
- Quality of sleep(Change from Baseline to 12 weeks (after intervention))
- Pain in hands and feet(Change from Baseline to 12 weeks (after intervention))
- General physical functioning and mobility(Change from Baseline to 12 weeks (after intervention))
- Breast cancer quality of life(Change from baseline to 12 weeks (after intervention))
- Handgrip strength test(Change from Baseline to 12 weeks (after intervention))
- Body composition(Change from Baseline to 12 weeks (after intervention))
研究者
Irene Cantarero Villanueva
Principal Investigator
Universidad de Granada