Effect of Salt Solution Immersion Bath on Cancer in Vivo.

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

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

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Drug: 25% Hypertonic Saline Bath; Other: 0.9% Isotonic Saline Bath

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Rafik Batroussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Group - 25% Saline Bath; 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; 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%).
Placebo Comparator: Control Group - 0.9% 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; 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rafik Batroussy
• Investigators: Study Chair: Rafik Batroussy, Independent Researcher

Publications and helpful links

General 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2020
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Estimated): March 1, 2021

Study Registration Dates

• First Submitted: December 21, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No