CancerNCT04210726
Effect of Salt Solution Immersion Bath on Cancer in Vivo.
A study testing 25% Hypertonic Saline Bath and 0.9% Isotonic Saline Bath in people with Cancer, run by Rafik Batroussy at 1 site in Canada.
Trial summary
This Study evaluates the effectiveness of Hypertonic Saline Bath in reducing the Cancer nodules' size, number and SUVmax. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- 25% Hypertonic Saline Bath and 0.9% Isotonic Saline Bath
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with the following medical conditions will be excluded:
- Kidney diseases
- Dialysis
- Fever
- On Blood Thinners or with any Coagulation disorder
- History of stroke
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.
This Study evaluates the effectiveness of Hypertonic Saline Bath in reducing the Cancer nodules' size, number and SUVmax.
Read the 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.
- Conditions
- Cancer
- Being tested
- 25% Hypertonic Saline Bath, 0.9% Isotonic Saline Bath
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% Hypertonic Saline BathDrug
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%).
0.9% Isotonic Saline BathOther
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%).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: 0.9% Isotonic Saline Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Working on complying with the Research Ethics Board requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafik Batroussy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafik Batroussy, Batroussy, Rafik
- Investigators
- Rafik Batroussy, Study chair, Independent Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210726
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2023
- First submitted
- 21 Dec 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16271440Machado 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.
PubMed 19799976
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Human Body Immersion in Hypertonic Saline Solution on Cancer Nodules' Size, Number and Its Metastasis Properties in Vivo.
- ClinicalTrials.gov ID
- NCT04210726
- Acronym / sponsor ID
- 001
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Working on complying with the Research Ethics Board requirements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rafik BatroussyUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group - 25% Saline Bath | Active comparator | Drug: 25% Hypertonic Saline BathThe 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 | Placebo comparator | Other: 0.9% Isotonic Saline BathThe 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 |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Kidney diseases
- Dialysis
- Fever
- On Blood Thinners or with any Coagulation disorder
- History of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25% Hypertonic Saline Bath25% 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%). | Drug | Active Group - 25% Saline Bath |
| 0.9% Isotonic Saline Bath0.9% 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%). | Other | Control Group - 0.9% Saline Bath |
Primary outcome
Reduction in Tumors size
Time frame: 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 numbers
Time frame: 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 lesions SUVmax (FDG-Maximum Standardized Uptake Values)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 16271440McIntyre 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.
- Background: PubMed 19799976Machado 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.
- Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.Link provided by the sponsor.
- High Salt Inhibits Tumor Growth by Enhancing Anti-tumor Immunity.Link provided by the sponsor.
- Permeability Of The Skin: A Review Of Major Concepts And Some New Developments.Link provided by the sponsor.
- Cell swelling, softening and invasion in a three-dimensional breast cancer model.Link provided by the sponsor.
- Cell Stiffness May Indicate Likelihood of Cancer Metastasis.Link provided by the sponsor.
- The Dysfunction of Metabolic Controlling of Cell Hydration Precedes Warburg Phenomenon in CarcinogenesisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafik Batroussy study chair
Independent Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25% Hypertonic Saline Bath and 0.9% Isotonic Saline Bath in people with Cancer, run by Rafik Batroussy at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Tumors size (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.