Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Melanoma size
Study Overview
Brief Summary
This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Water (Other)
Outcomes
Primary Outcomes
Melanoma size
Time Frame: 6 month
Change in Melanoma's parameters such as length and width.
Melanoma number
Time Frame: 6 month
Change in Melanoma number
Secondary Outcomes
No secondary outcomes reported
Investigators
Rafik Batroussy
Registered Pharmacist, Director
Batroussy, Rafik