Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Total Neuropathy Scale (TNS)
研究概览
简要总结
Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.
There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.
Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 & FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.
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
- 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
- •diagnosed with cancer and assigned to receive a chemotherapeutic regimen containing at least one of the following agents:
- •a platinum analog, e.g., cisplatin, carboplatin, oxaliplatin
- •a vinca alkaloid, e.g., vincristine
- •a taxane, e.g., paclitaxel, docetaxel
- •thalidomide or lenalidomide
- •bortezomib
- •Physical capability that allows the performance of the training program implemented within the experimental intervention or the control intervention arm
排除标准
- •Known polyneuropathy of any kind or any polyneuropathic signs or symptoms at baseline
- •Abnormal electroneurographic findings at baseline
- •Known metastasis to the central or peripheral nervous system
- •Any physical or mental handicap that would hamper the performance of the training program implemented within the intervention arms
- •Family history positive for any hereditary polyneuropathy
- •Known history of alcohol or illegal drug abuse or any constellation of lab values suggesting alcoholism
结局指标
主要结局
Total Neuropathy Scale (TNS)
时间窗: up to week 24 (and 3 & 6 month follow up)
The TNS is based on symptoms, signs and basic instrumental evaluations and provides a much larger range of scoring values (0 - 40) than common oncological toxicity scales such as the National Cancer Institute (NCI) Common Toxicity Criteria (ranging from 0 - 4, cf. http://ctep.cancer.gov/forms), thus allowing the severity of CIPN to be graded more precisely. The TNS has so far been used to assess the neurotoxicity of various CIPN-relevant chemotherapeutic agents, and its results are clearly correlated with the clinically relevant results of NCI Common Toxicity Criteria, Ajani's and Eastern Cooperative Oncology Group toxicity scales, which are commonly used by oncologists.28-32 Within the PIC-Study the TNS-reduced will the primary endpoint. The TNS-reduced score excludes QST (quantitative sensory testing) vibration testing resulting in a TNS scale from 0-36.
次要结局
- EORTC QLQ-C30(up to week 24 (and 3 & 6 month follow up))
- Centre of Pressure (COP)(up to week 24 (and 3 & 6 month follow up))
- FACT-GOG-Ntx(prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up))
- Strength Performance(up to week 24)
- EORTC QLQ-CIPN20(prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up))
- Multidimensional Fatigue Inventory (MFI)(up to week 24 (and 3 & 6 month follow up))
- Cardiopulmonary Fitness(up to week 24 (and 3 & 6 month follow up))
- Pittsburgh Sleep Quality Index (PSQI)(up to week 24 (and 3 & 6 month follow up))
- Short QUestionnaire to ASsess Health-enhancing Physical Activity(up to week 24 (and 3 & 6 month follow up))