An interventional study of 25% Hypertonic Saline Bath and 0.9% Isotonic Saline Bath in Cancer, sponsored by Rafik Batroussy. Withdrawn at 1 site in Canada. Open to participants aged 5 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Rafik Batroussy · Not applicable, Interventional, and Treatment
This Study evaluates the effectiveness of Hypertonic Saline Bath in reducing the Cancer nodules' size, number and SUVmax.
Many previous studies have shown that the 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 nutrient to the rapidly-dividing Cancer cells. This study tests the hypothesis that disrupting the water content of blood could lead to increasing its Tonicity and hence withdrawing water from the Cancer cells by Osmosis, which can result in disrupting the growth of the Cancer cell itself. This disruption of Blood Water content can be achieved using Osmotic Pressure differential via immersing the whole body in Hypertonic Saline Solution for a certain amount of time, thus making the Blood more Hypertonic relative to the cells of the body and of the cancer, leading to water withdrawal from the cells of the body and of the cancer. While body's cells can sustain temporary dehydration, Cancer cells could be negatively affected.
Rafik Batroussy is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with the following medical conditions will be excluded:
The Active group's patients will separately have an immersion bath in 25% Sea Salt in Water solution (made by adding pure Sodium Chloride in the form of Sea Salt to Tap Water Bath) at a temperature comfortable to every participant (please note that Solubility of Sodium Chloride in Water does not change significantly with change in temperature, therefore the concentration will remain the same regardless of water temperature), whereas the bath solution is in direct contact with the skin, for 30 minutes once daily for 7 consecutive days, in addition to their standard treatments they receive from their health care providers.
Drug: 25% Hypertonic Saline Bath
The Control group's patients will separately have a bath in 0.9% Sea Salt in Water (Isotonic solution, made by adding Sodium Chloride in form of Sea Salt to Tap Water) at a comfortable temperature whereas the bath solution is in direct contact with the skin, for 30 minutes once daily for 7 consecutive days, in addition to their standard treatments they receive from their health care providers
Other: 0.9% Isotonic Saline Bath
25% Sea Salt (mainly Sodium Chloride - NaCl) in Tap Water Immersion Bath (made by adding Sodium Chloride in the form of Sea Salt to Tap Water to a concentration of 25%).
0.9% Sea Salt (mainly Sodium Chloride - NaCl) in Tap Water Immersion Bath (made by adding Sodium Chloride in the form of Sea Salt to Tap Water to a concentration of 0.9%).
Reduction in Tumors size
Tumor responses are evaluated in terms of change in tumor size represented by the linear measurements of all targeted lesions. The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the measured Cancer Cells sizes/dimensions for the same nodules between the two groups using a One-Way ANOVA test.
Time frame: 6 month
Reduction in Tumors lesions numbers
Tumor responses are evaluated in terms of change in tumor lesions number. The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the Cancer lesions number for the same nodules between the two groups using a One-Way ANOVA test.
Time frame: 6 month
Reduction in Tumors lesions SUVmax (FDG-Maximum Standardized Uptake Values)
Tumor responses are evaluated in terms of change in tumor SUV max (FDG-Maximum Standardized Uptake Values). The Hypertonic Sea Salt Bath intervention will be considered effective if there is a statistically-significant reduction in Means of the measured Cancer lesions SUVmax values for the same nodules between the two groups using a One-Way ANOVA test.
Time frame: 6 month
Plan to share: No
This study is withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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