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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05854589
• Other study ID #: 003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Batroussy, Rafik
• Contact: Rafik Batroussy, BPharm
• Phone: 1-403-796-4441
• Email: rafikbatroussy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• Sodium Chloride Granules
Sodium Chloride crystals

Other:
• Water
Plain distilled water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rafik Batroussy

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melanoma size	Change in Melanoma's parameters such as length and width.	6 month
Primary	Melanoma number	Change in Melanoma number	6 month

External Links

•   Cell Stiffness May Indicate Likelihood of Cancer Metastasis.
•   Cell swelling, softening and invasion in a three-dimensional breast cancer model.
•   High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity.
•   Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.
•   The Dysfunction of Metabolic Controlling of Cell Hydration Precedes Warburg Phenomenon in Carcinogenesis