Melanoma (Skin)Phase 2NCT05854589
Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
A Phase 2 study testing Sodium Chloride Granules and Water in people with Melanoma (Skin), run by Rafik Batroussy.
Trial summary
This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Sodium Chloride Granules and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.
Read the 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)
- Being tested
- Sodium Chloride Granules, Water
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride GranulesDrug
Sodium Chloride crystals
WaterOther
Plain distilled water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanoma size
Change in Melanoma's parameters such as length and width.
Measured: 6 month
Melanoma number
Change in Melanoma number
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafik Batroussy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafik Batroussy, Batroussy, Rafik
- Investigators
- Rafik Batroussy, BPharm, Study chair, Independent Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854589
- Sponsor's protocol ID
- 003
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16271440Machado 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.
PubMed 19799976
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
- ClinicalTrials.gov ID
- NCT05854589
- Acronym / sponsor ID
- 003
- Conditions
- Melanoma (Skin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rafik BatroussyUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group - Sodium Chloride Crystal Topical | Active comparator | Drug: Sodium Chloride GranulesEach 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. |
| Control Group - Plain Water topical application | Placebo comparator | Other: WaterEach 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. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride GranulesSodium Chloride crystals | Drug | Active Group - Sodium Chloride Crystal Topical |
| WaterPlain distilled water | Other | Control Group - Plain Water topical application |
Primary outcome
Melanoma size
Time frame: 6 month
Change in Melanoma's parameters such as length and width.
Melanoma number
Time frame: 6 month
Change in Melanoma number
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 16271440McIntyre 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.
- Background: PubMed 19799976Machado 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.
- Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.Link provided by the sponsor.
- High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity.Link provided by the sponsor.
- Cell swelling, softening and invasion in a three-dimensional breast cancer model.Link provided by the sponsor.
- Cell Stiffness May Indicate Likelihood of Cancer Metastasis.Link provided by the sponsor.
- The Dysfunction of Metabolic Controlling of Cell Hydration Precedes Warburg Phenomenon in CarcinogenesisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafik Batroussy, BPharm study chair
Independent Researcher
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Chloride Granules and Water in people with Melanoma (Skin), run by Rafik Batroussy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafik Batroussy, BPharm (1-403-796-4441, rafikbatroussy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanoma size (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.