To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.
NCT ID:
NCT05854589
Condition:
Melanoma (Skin)
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sodium Chloride Granules
Description:
Sodium Chloride crystals
Arm group label:
Active Group - Sodium Chloride Crystal Topical
Intervention type:
Other
Intervention name:
Water
Description:
Plain distilled water
Arm group label:
Control Group - Plain Water topical application
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.
Criteria for 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.
Gender:
All
Minimum age:
5 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Rafik Batroussy
Agency class:
Other
Source:
Batroussy, Rafik
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05854589
https://www.nature.com/articles/nchem.2021
https://www.frontiersin.org/articles/10.3389/fimmu.2019.01141/full
http://royalsocietypublishing.org/doi/abs/10.1098/rspb.1932.0065
https://www.nature.com/articles/s41567-019-0680-8
https://www.genengnews.com/news/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
