Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Melanoma size
研究概览
简要总结
This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.
详细描述
Many previous studies have shown that 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 nutrients to the rapidly-dividing Cancer cells. This study tests the hypothesis that reducing the water content of Melanoma could lead to increasing its tonicity and hence inhibiting its growth. This reduction of water content can be achieved using Osmotic Pressure differential via applying highly saline solution - made by Sodium Chloride crystals wet with water - directly on the Melanoma for a certain amount of time, thus leading to water withdrawal from Melanoma cells. While the surrounding healthy skin cells can sustain temporary dehydration, Melanoma 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
- None
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 clinically-confirmed Melanoma (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 USA.
- •Patient who do not meet the Inclusion Criteria but still wish to participate will be accepted as Observational participants, but their Melanoma measurements will be not be taken into account when analyzing the Study statistically.
排除标准
- •Skin eczema and/or other skin conditions contraindicated to skin dehydration.
- •Ulcers or open wounds close to Melanoma
- •Any medical condition that might cause the patient to lose consciousness
- •Participants who are not residents of USA.
研究组 & 干预措施
Active Group - Sodium Chloride Crystal Topical
Each patient of the Active group will have their Melanoma covered by 2 drops of water, followed by applying Sodium Chloride granules to saturate the melanoma surface then add 2 more drops of water, then cover the NaCl-granules-covered Melanoma with a bandage. The bandage will stay in place for 12 hours daily and the procedure will be repeated daily for a total of 7 consecutive days, in addition to their standard treatments they receive from their health care providers, if any.
干预措施: Sodium Chloride Granules (Drug)
Control Group - Plain Water topical application
Each patient of the Control group will have their Melanoma covered by 4 drops of water, then covered by a bandage. The bandage will stay in place for 12 hours daily and the procedure will be repeated daily for a total of 7 consecutive days, in addition to their standard treatments they receive from their health care providers, if any.
干预措施: Water (Other)
结局指标
主要结局
Melanoma size
时间窗: 6 month
Change in Melanoma's parameters such as length and width.
Melanoma number
时间窗: 6 month
Change in Melanoma number
次要结局
未报告次要终点
研究者
Rafik Batroussy
Registered Pharmacist, Director
Batroussy, Rafik