Clinical trial NCT05854589: Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
Official title: Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma (Skin)
Lead sponsor: Batroussy, Rafik
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled study, whereas a number of patients with clinically-diagnosed skin Melanoma (any location and any stage), and who were poorly responsive to at least one cycle of conventional and standard therapy, are equally divided into 2 groups, Active and Control groups. 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. Each patient of the Control group will undergo the same treatment as the Active group patients minus the Sodium Chloride granules.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Melanoma size
timeFrame: 6 month
measure: Melanoma number
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Independent Researcher
name: Rafik Batroussy, BPharm
role: STUDY_CHAIR
References:
citation: McIntyre GI. Cell hydration as the primary factor in carcinogenesis: A unifying concept. Med Hypotheses. 2006;66(3):518-26. doi: 10.1016/j.mehy.2005.09.022. Epub 2005 Nov 3.
citation: Machado M, Salgado TM, Hadgraft J, Lane ME. The relationship between transepidermal water loss and skin permeability. Int J Pharm. 2010 Jan 15;384(1-2):73-7. doi: 10.1016/j.ijpharm.2009.09.044. Epub 2009 Sep 30.