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

NCT05854589 | Unknown Phase 2

• 1 other identifier: 003
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (2)

• Melanoma size

  Change in Melanoma's parameters such as length and width.

  6 month

• Melanoma number

  Change in Melanoma number

  6 month

Study Arms (2)

Active Group - Sodium Chloride Crystal Topical

ACTIVE COMPARATOR

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.

Drug: Sodium Chloride Granules

Control Group - Plain Water topical application

PLACEBO COMPARATOR

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.

Other: Water

Interventions

Sodium Chloride Granules DRUG

Sodium Chloride crystals

Active Group - Sodium Chloride Crystal Topical

Water OTHER

Plain distilled water

Control Group - Plain Water topical application

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rafik Batroussy: lead

Related Publications (2)

• 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.

  PMID: 16271440 BACKGROUND

• 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.

  PMID: 19799976 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Melanoma

Interventions

Water

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Rafik Batroussy, BPharm

  Independent Researcher

  STUDY CHAIR

Central Study Contacts

Rafik Batroussy, BPharm

CONTACT

1-403-796-4441; rafikbatroussy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registered Pharmacist, Director

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 11, 2023
• Study Start: August 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: June 30, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share