Effect of Salt Solution Immersion Bath on Cancer in Vivo.

Cancer Clinical Trial

Official title:

Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04210726
• Other study ID #: 001
• Status: Withdrawn
• Phase: N/A
• Start date: March 2020
• Est. completion date: March 2021

Study information

• Verified date: July 2023
• Source: Batroussy, Rafik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Study evaluates the effectiveness of Hypertonic Saline Bath in reducing the Cancer nodules' size, number and SUVmax.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with PET/CT scan-confirmed Cancer (any type, 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 Calgary Alberta Exclusion Criteria:

Patients with the following medical conditions will be excluded:

1. Kidney diseases

2. Dialysis

3. Fever

4. On Blood Thinners or with any Coagulation disorder

5. History of stroke

6. Hypernatraemia

7. Hypotension (Low Blood Pressure)

8. Hypovolemia/Dehydration

9. Tachycardia (Rapid Heart rate)

10. Epilepsy

11. Open wounds

12. Any medical condition that might cause the patient to lose consciousness

13. Participants who cannot tolerate thirst during the 30 minutes bath.

14. Participants who are not residents of Calgary Alberta Canada with a valid Alberta Health Card.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 25% Hypertonic 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%).

Other:
• 0.9% Isotonic Saline Bath
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%).

Locations

Country	Name	City	State
Canada	Rafik Batroussy	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Rafik Batroussy

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

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