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

NCT ID: NCT05854589

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-06-30

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sodium Chloride Granules

Intervention Type: DRUG

Sodium Chloride crystals

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.

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: OTHER

Plain distilled water

Interventions

Sodium Chloride Granules

Sodium Chloride crystals

Intervention Type: DRUG

Water

Plain distilled water

Intervention Type: OTHER

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.

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rafik Batroussy

OTHER

Sponsor Role: lead

Responsible Party

Rafik Batroussy

Registered Pharmacist, Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rafik Batroussy, BPharm

Role: STUDY_CHAIR

Independent Researcher

Central Contacts

Rafik Batroussy, BPharm

Role: CONTACT

rafikbatroussy@hotmail.com

1-403-796-4441

References

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.

Reference Type: BACKGROUND

PMID: 16271440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19799976 (View on PubMed)

Related Links

https://www.nature.com/articles/nchem.2021

Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.

https://www.frontiersin.org/articles/10.3389/fimmu.2019.01141/full

High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity.

http://royalsocietypublishing.org/doi/abs/10.1098/rspb.1932.0065

The osmotic passage of water and gases through the human skin.

https://www.nature.com/articles/s41567-019-0680-8

Cell swelling, softening and invasion in a three-dimensional breast cancer model.

https://www.genengnews.com/news/cell-stiffness-may-indicate-likelihood-of-cancer-metastasis/

Cell Stiffness May Indicate Likelihood of Cancer Metastasis.

https://www.longdom.org/open-access/the-dysfunction-of-metabolic-controlling-of-cell-hydration-precedes-warburg-phenomenon-in-carcinogenesis-jbb.10000e59.pdf

The Dysfunction of Metabolic Controlling of Cell Hydration Precedes Warburg Phenomenon in Carcinogenesis

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id