Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.

Rafik Batroussy

Status and phase: Not yet enrolling; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: Sodium Chloride Granules; Other: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT05854589

003

Details and patient eligibility

About

This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Active Group - Sodium Chloride Crystal Topical

Active Comparator group

Description:

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.

Treatment:

Drug: Sodium Chloride Granules

Control Group - Plain Water topical application

Placebo Comparator group

Description:

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.

Treatment:

Other: Water