Effect of Salt Solution Immersion Bath on Cancer in Vivo.

NCT04210726 | Withdrawn

• 1 other identifier: 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Active Group - 25% Saline Bath

ACTIVE COMPARATOR

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

Control Group - 0.9% Saline Bath

PLACEBO COMPARATOR

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

Interventions

25% Hypertonic Saline Bath DRUG

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%).

Active Group - 25% Saline Bath

0.9% Isotonic Saline Bath OTHER

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%).

Control Group - 0.9% Saline Bath

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with the following medical conditions will be excluded:
• Kidney diseases
• Dialysis
• Fever
• On Blood Thinners or with any Coagulation disorder
• History of stroke
• Hypernatraemia
• Hypotension (Low Blood Pressure)
• Hypovolemia/Dehydration
• Tachycardia (Rapid Heart rate)
• Epilepsy
• Open wounds
• Any medical condition that might cause the patient to lose consciousness
• Participants who cannot tolerate thirst during the 30 minutes bath.
• Participants who are not residents of Calgary Alberta Canada with a valid Alberta Health Card.

Sponsors & Collaborators

• Rafik Batroussy: lead

Study Sites (1)

Rafik Batroussy

Calgary, Alberta, Canada

Location

Related Publications (2)

• 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.

  PMID: 16271440 BACKGROUND

• 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.

  PMID: 19799976 BACKGROUND

Related 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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rafik Batroussy

  Independent Researcher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 26, 2019
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)