Effect of Salt Solution Immersion Bath on Cancer in Vivo.

• Sponsor: Rafik Batroussy (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04210726
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: 25% Hypertonic Saline Bath; Other: 0.9% Isotonic Saline Bath	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Participant)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

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%).

Outcome Measures

Primary Outcome Measures

1. Reduction in Tumors size [6 month]

   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.

2. Reduction in Tumors lesions numbers [6 month]

   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.

3. Reduction in Tumors lesions SUVmax (FDG-Maximum Standardized Uptake Values) [6 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rafik Batroussy	Calgary	Alberta	Canada

Sponsors and Collaborators

• Rafik Batroussy

Investigators

• Study Chair: Rafik Batroussy, Independent Researcher

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.
• High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity.
• The osmotic passage of water and gases through the human skin.
• Permeability Of The Skin: A Review Of Major Concepts And Some New Developments.
• 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

Publications

• 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.
• McIntyre GI. Cell hydration as the primary factor in carcinogenesis: A unifying concept. Med Hypotheses. 2006;66(3):518-26. Epub 2005 Nov 3.

• Responsible Party: Rafik Batroussy, Principal Investigator, Batroussy, Rafik
• ClinicalTrials.gov Identifier: NCT04210726
• Other Study ID Numbers: 001
• First Posted: Dec 26, 2019
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 30, 2022