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Working on complying with the Research Ethics Board requirements.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group - 25% Saline Bath | Active Comparator | 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. |
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| Control Group - 0.9% Saline Bath | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25% Hypertonic Saline Bath | Drug | 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%). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
Patients with the following medical conditions will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Rafik Batroussy | Independent Researcher | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rafik Batroussy | Calgary | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16271440 | Background | 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. | |
| 19799976 | 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. |
| Label | URL |
|---|---|
| Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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A pilot randomized blinded controlled study, whereas a number of patients with clinically-diagnosed Cancer (any type, any location and any stage), and who were poorly responsive to at least one cycle of conventional and standard therapy (Chemotherapy or Radiation therapy), are equally divided into 2 groups, Active and Control groups. The Active group patients will separately have an immersion bath in 25% Sea Salt in Water solution at a temperature comfortable to every patient, 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. The Control group's patients will separately have a bath in 0.9% Sea Salt in 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.
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Participants will not know which Group (Active/Control) they are assigned to, only the Investigator will know. The amount of Salt added to each bath (and hence the concentration of each bath) will not be known by Participants. Assignment will be random using a simple computer program.
| 0.9% Isotonic Saline Bath | Other | 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%). |
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| High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity. | View source |
| Cell swelling, softening and invasion in a three-dimensional breast cancer model. | View source |
| Cell Stiffness May Indicate Likelihood of Cancer Metastasis. | View source |
| The Dysfunction of Metabolic Controlling of Cell Hydration Precedes Warburg Phenomenon in Carcinogenesis | View source |