Effect of Salt Solution Immersion Bath on Cancer in Vivo.

Not Applicable

Withdrawn

• Conditions: Cancer
• Interventions: Drug: 25% Hypertonic Saline Bath; Other: 0.9% Isotonic Saline Bath

• Registration Number: NCT04210726
• Lead Sponsor: Rafik Batroussy

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-12-21
• Study First Submitted QC: 2019-12-22
• Study First Posted: 2019-12-26
• Study Start: 2020-03
• Primary Completion: 2020-12
• Study Completion: 2021-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Group - 25% Saline Bath	25% Hypertonic 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.
Control Group - 0.9% Saline Bath	0.9% Isotonic 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

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Rafik Batroussy; 🇨🇦 Calgary, Alberta, Canada