Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking.
Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits.
We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up.
We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding against study arm
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •oncological patients with neurologically confirmed CIPN
- •age: 18-80 years
- •performance status of 0-2 according to the toxicity and response criteria of the Eastern Cooperative Oncology Group
- •patients underwent neurotoxic chemotherapy with one of the following agents: Taxanes (docetaxel with a cumulative dose of ≥ 225mg/m2 or paclitaxel with a cumulative dose of ≥ 525mg/m2), Vinca-alkaloids (vincristine with a cumulative dose of ≥ 4.2mg/m2 or vinblastine with a cumulative dose of 24mg/m2), Platinum-derivatives (Oxaliplatin with a cumulative dose of ≥ 510mg/m2, Cisplatinum with a cumulative dose of ≥ 200mg/m2)
排除标准
- •pre-existing neuropathy of other cause (e.g. diabetes)
- •given contraindications for WBV (instable osteolysis, osteosynthesis, acute thrombosis, foot ulcers and a fracture of a lower extremity in the last two years)
- •a myocardial infarction, angina pectoris or heart disease (NYHA III-IV) within the past six months
- •a mental condition or lack of the German language that prevents the understanding of the written informed consent
- •metastases of the central nervous system and epilepsy
结局指标
主要结局
FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]
时间窗: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
It will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. This questionnaire has been validated and is widely applied in clinical practise. It contains eleven items which allow an assessment of the extent of PNP symptoms - from "not at all" to "very much".
次要结局
- Peripheral deep sensitivity(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Nerve conduction velocity(Baseline)
- Compound muscle action potentials (CMAP)(Baseline)
- Sensory nerve action potentials (SNAPs)(Baseline)
- Physical activity questionnaire(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Muscular strength(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Quality of life - questionnaire(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Distal motor latency(Baseline)
- Sense of position(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Perception of touch(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- EMG recordings(1 week (first 2 training sessions))
- Postural control(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- Reflex action(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
- CIPN-related pain(Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up)
研究者
Oliver Faude
Deputy Head Exercise and Movement Science
University of Basel