Clinical trial NCT04210726: Effect of Salt Solution Immersion Bath on Cancer in Vivo.
Official title: Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Lead sponsor: Batroussy, Rafik
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Tumors size
timeFrame: 6 month
measure: Reduction in Tumors lesions numbers
timeFrame: 6 month
measure: Reduction in Tumors lesions SUVmax (FDG-Maximum Standardized Uptake Values)
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rafik Batroussy
state: Alberta
Study officials:
affiliation: Independent Researcher
name: Rafik Batroussy
role: STUDY_CHAIR
References:
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.
citation: 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.