Efficacy and Safety of a Tablet Containing Palmitoyethanolamide, Alpha Lipoic Acid, Vitamin B12, Vitamin B6 , Vitamin B1, Nicotinamide, Magnesium, Zinc, Vitamin E, and Superoxide of Dismutase in Individuals Receiving Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Neuropathic Pain Symptom Inventory
研究概览
简要总结
Administration of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
详细描述
Investigation of effectiveness and safety of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with cancer that have not received yet their treatment
- •Patients that will be treated with platinum agents or taxanes
排除标准
- •Not receiving dietary supplement
- •Have already neuropathy
- •Have already started chemotherapy
- •Patients with uncontrolled diabetes
- •-- Patients with chronic kidney disease
- •Patiens with recent cardiovascular incident
结局指标
主要结局
Neuropathic Pain Symptom Inventory
时间窗: 6 months
scale for neuropathic pain symptoms. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. In addition, we propose to derive five subscores corresponding to the mean scores of the items belonging to each of the five factors identified in the factor analysis. three questions based on clinical examination to evaluate the intensity of pain evoked by brushing, pressure, cold or warm stimuli in the painful area on four-point categorical scales (absent, mild, moderate, severe). Clinical examination of evoked pain was standardized: tactile allodynia was evaluated with a soft brush (three movements), pressure allodynia was evoked by blunt pressure with a finger at a pressure that does not provoke pain in a normal area and glass tubes filled with hot (38-408C) or cold (22-248C) water were used to evaluate thermal allodynia.
PAIN Detect score
时间窗: 6 months
score for neuropathic pain, higher values indicate that the pain is neuropathic. A Pain DETECT score between-1 and 38 indicates the likelihood of a neuropathic pain component
Neuropathic Pain Symptom Inventory
时间窗: 6 months
scale for neuropathic pain symptoms. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. In addition, we propose to derive five subscores corresponding to the mean scores of the items belonging to each of the five factors identified in the factor analysis. three questions based on clinical examination to evaluate the intensity of pain evoked by brushing, pressure, cold or warm stimuli in the painful area on four-point categorical scales (absent, mild, moderate, severe). Clinical examination of evoked pain was standardized: tactile allodynia was evaluated with a soft brush (three movements), pressure allodynia was evoked by blunt pressure with a finger at a pressure that does not provoke pain in a normal area and glass tubes filled with hot (38-408C) or cold (22-248C) water were used to evaluate thermal allodynia.
PAIN Detect score
时间窗: 6 months
score for neuropathic pain, higher values indicate that the pain is neuropathic. A Pain DETECT score between-1 and 38 indicates the likelihood of a neuropathic pain component
次要结局
- Nerve conduction velocity(6months)
- Visual Analogue scale(6 months)
- Vibration perception threshold(6 months)
- Nerve conduction velocity(6months)
研究者
Prof. Triantafyllos Didangelos
Professor of Internal Medicine and Diabetology
Aristotle University Of Thessaloniki