Effect of Salt Solution Immersion Bath on Cancer in Vivo.

Rafik Batroussy

Status: Withdrawn

Conditions: Cancer

Treatments: Other: 0.9% Isotonic Saline Bath; Drug: 25% Hypertonic Saline Bath

Study type: Interventional

Funder types: Other

Identifiers

NCT04210726

001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 5 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Active Group - 25% Saline Bath

Active Comparator group

Description:

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.

Treatment:

Drug: 25% Hypertonic Saline Bath

Control Group - 0.9% Saline Bath

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% Isotonic Saline Bath