Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Reduction in Tumors lesions numbers
研究概览
简要总结
This Study evaluates the effectiveness of Hypertonic Saline Bath in reducing the Cancer nodules' size, number and SUVmax.
详细描述
Many previous studies have shown that the Cancer cells are over-hydrated, and that Hyponatraemia exists in many cases of Cancer. The Cancer cell's viability depends on Angiogenesis and formation of blood vessels that carry water and nutrient to the rapidly-dividing Cancer cells. This study tests the hypothesis that disrupting the water content of blood could lead to increasing its Tonicity and hence withdrawing water from the Cancer cells by Osmosis, which can result in disrupting the growth of the Cancer cell itself. This disruption of Blood Water content can be achieved using Osmotic Pressure differential via immersing the whole body in Hypertonic Saline Solution for a certain amount of time, thus making the Blood more Hypertonic relative to the cells of the body and of the cancer, leading to water withdrawal from the cells of the body and of the cancer. While body's cells can sustain temporary dehydration, Cancer cells could be negatively affected.
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 (Participant)
盲法说明
Participants will not know which Group (Active/Control) they are assigned to, only the Investigator will know. The amount of Salt added to each bath (and hence the concentration of each bath) will not be known by Participants. Assignment will be random using a simple computer program.
入排标准
- 年龄范围
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PET/CT scan-confirmed Cancer (any type, any location and any stage) who have poorly responded to at least one cycle of conventional and standard therapy (Chemotherapy, Radiation or Drug therapy) .
- •Age 5 to 80 years old
- •Life expectancy of at least 1 year
- •Can understand and read English
- •Lives in Calgary Alberta
排除标准
- •Patients with the following medical conditions will be excluded:
- •Kidney diseases
- •On Blood Thinners or with any Coagulation disorder
- •History of stroke
- •Hypernatraemia
- •Hypotension (Low Blood Pressure)
- •Hypovolemia/Dehydration
- •Tachycardia (Rapid Heart rate)
- •Open wounds
- •Any medical condition that might cause the patient to lose consciousness
- •Participants who cannot tolerate thirst during the 30 minutes bath.
- •Participants who are not residents of Calgary Alberta Canada with a valid Alberta Health Card.
研究组 & 干预措施
Active Group - 25% Saline Bath
The Active group's patients will separately have an immersion bath in 25% Sea Salt in Water solution (made by adding pure Sodium Chloride in the form of Sea Salt to Tap Water Bath) at a temperature comfortable to every participant (please note that Solubility of Sodium Chloride in Water does not change significantly with change in temperature, therefore the concentration will remain the same regardless of water temperature), whereas the bath solution is in direct contact with the skin, for 30 minutes once daily for 7 consecutive days, in addition to their standard treatments they receive from their health care providers.
干预措施: 25% Hypertonic Saline Bath (Drug)
Control Group - 0.9% Saline Bath
The Control group's patients will separately have a bath in 0.9% Sea Salt in Water (Isotonic solution, made by adding Sodium Chloride in form of Sea Salt to Tap Water) at a comfortable temperature whereas the bath solution is in direct contact with the skin, for 30 minutes once daily for 7 consecutive days, in addition to their standard treatments they receive from their health care providers
干预措施: 0.9% Isotonic Saline Bath (Other)
结局指标
主要结局
Reduction in Tumors lesions numbers
时间窗: 6 month
Tumor responses are evaluated in terms of change in tumor lesions number. The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the Cancer lesions number for the same nodules between the two groups using a One-Way ANOVA test.
Reduction in Tumors size
时间窗: 6 month
Tumor responses are evaluated in terms of change in tumor size represented by the linear measurements of all targeted lesions. The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the measured Cancer Cells sizes/dimensions for the same nodules between the two groups using a One-Way ANOVA test.
Reduction in Tumors lesions SUVmax (FDG-Maximum Standardized Uptake Values)
时间窗: 6 month
Tumor responses are evaluated in terms of change in tumor SUV max (FDG-Maximum Standardized Uptake Values). The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the measured Cancer lesions SUVmax values for the same nodules between the two groups using a One-Way ANOVA test.
次要结局
未报告次要终点
研究者
Rafik Batroussy
Principal Investigator
Batroussy, Rafik