TNBC - Triple-Negative Breast CancerPhase 1NCT05957939
Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
A Phase 1 study testing Alkaline Glucosodiene Molecules in people with TNBC - Triple-Negative Breast Cancer, run by Ministry of Health, Saudi Arabia.
Trial summary
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of estrogen, progesterone, and human epidermal growth factor receptors TNBC makes up almost… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Alkaline Glucosodiene Molecules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Phase 1
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type of patient: Female patient
- Age: 18-55 years
- Type of breast cancer: metastatic breast cancer hormonal or triple-negative breast cancer
Who cannot join
- with other co-morbidities like diabetes or hypertension
- with other type of cancers
- on other chemotherapy or immunotherapy or hormonal therapy
About this study
Official title: Targeting Triple-negative Breast Cancer or ER-positive, PR Positive her2 Negative by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of estrogen, progesterone, and human epidermal growth factor receptors TNBC makes up almost 15% of all invasive breast cancers, and of all breast tumor subtypes, it has the worst overall survival and the highest rate of metastatic occurrence. Cytotoxic chemotherapy is the main established systemic therapy for early and advanced TNBC disease at the moment because there is no authorized targeted therapy. Despite the fact that chemotherapy greatly improves clinical outcomes for TNBC patients, recurrence rates are still high and TNBC cancers frequently develop chemotherapeutic drug resistance ). In light of the few available therapy choices, so few choices for this subtype of breast cancer, and many cases are resistant to chemotherapy and recurrent and with a risk of high metastasis from previous literature and many experimental studies, the target of glucose environment is a promising weapon against this deadly type of breast cancer so glucose deprivation from tumor cells may cut the glucose entry as fuel to these cancer cells so this study uses a substitute energy fuel by using alkaline glucosodiene which is chemically invented by Maher M.AKL
Read the detailed description
Breast cancer is the most frequently diagnosed and the second largest cause of cancer-related deaths in women aged 29 to 59 worldwide[1-4]. It is a genetically heterogeneous illness. Breast cancer treatments available today may help increase patient survival. However, one-third of patients with aggressive triple-negative breast cancer (TNBC), which accounts for 17-20 percent of all breast cancers [5-7], may experience more relapses than patients with subtypes of breast cancer that express receptors for the hormones estrogen (ER), progesterone (PR), or human epidermal growth factor (HER-2). The 17-20 percent of TNBC patients who experience this eventually pass away from a distant metastatic disease[5, 8-10]. Although decades of research have improved our understanding of the issue, the pathobiology of breast cancer progression's basic mechanisms remain a mystery.Cancer is a genetic disease characterized by heritable defects in cellular regulatory mechanisms. Tumor cells must adapt their metabolism to survive and proliferate in the challenging conditions of the tumor microenvironment. To maintain uncontrolled cellular growth and survival, cancer cells alter their metabolism, which makes them dependent on a steady supply of nutrients and energy. Almost a century ago, the Warburg theory suggested that cancer cells consume glucose even in the presence of oxygen. Recent studies have confirmed that cancer cells indeed consume significantly more glucose than normal cells. Cancerous tumors require an acidic microenvironment with low oxygen levels for growth and spread. However, recent advances in pH measurement have shown that the intracellular pH of cancer cells is neutral or slightly alkaline compared to normal tissue cells. This finding indicates that not all tumors are highly acidic. Taking advantage of cancer cells' high glucose consumption, a strategy to lyse cancer cells is tested by means of glucose modifications that exploit the characteristics of their uncontrolled growth process.
From the study of the molecular structure to give him alkaline properties that enable him to make defects in the tumor structure and possibly achieve cell killing, this situation will have a killing effect on cancer cells if small molecules of toxic atoms (alkaline atoms) can be continuously supplied to them through food, due to the uncontrolled consumption of glucose molecules by cancer cells. This theory attempts to investigate by changing the atomic structure of glucose molecules to make them alkaline glucosodiene molecules as one of the methods to kill cancer cells. By preparing alkaline glucosodiene molecules and performing animal experiments and histological observations, it was shown that tumors without alkaline treatment showed a tendency to infiltrate and grow, while tumors treated with glucosodiene molecules showed complete disappearance of cell structure and nucleolysis, supporting the validity of the theory. Cancer cells are known to be more sensitive to heat and apoptosis than normal cells, and this property has been leveraged to develop glucosodiene molecules that induce tumor hyperthermia. The chemical mechanism of sodium processing in this approach is similar to the cathode reaction in electrochemotherapy. Cancer cells take up glucosodiene because they are capable of growing uncontrollably and lack the sophisticated brain function necessary to distinguish between glucose and modified glucose. Glucosodiene kills cancer cells by breaking down glucose molecules into carbon dioxide and water, generating energy that alkali elements utilize to dissolve cancer cells from within. This approach is effective for treating numerous types of cancer due to the uncontrolled development of cancer cells. The traditional approach of eliminating cancer cells is not applicable in this theory, as cancer cells are dissolved from within due to their uncontrollable consumption of glucose molecules. Cancer cells have an uncontrolled ability to multiply and consume glucose molecules. Glucosodiene molecules have been developed to exploit this characteristic by inducing tumor hyperthermia, which makes cancer cells more sensitive to heat and apoptosis. Glucosodiene breaks down glucose molecules into carbon dioxide and water, generating energy that is utilized by alkali elements to dissolve cancer cells from within. Cancer cells that consume sodium-laced glucose struggle to retain their rigid cell structure and instead disintegrate and dissolve into the bloodstream before being excreted as urine. This approach is particularly effective in treating numerous types of cancer because cancer cells predominantly grow in lumped form, allowing for a the localized concentration of alkali elements. so this clinical trial uses case with TNBC ( ) and studies the environment of the tumor at many different environments like high glucose, zinc, insulin, interleukin -6 .
Glucosodiene may hasten the death of aging cells, which resist elimination. The breakdown of sugar molecules without oxygen causes acid, but discomfort subsides when cells take up glucosodiene. The body's T cells eliminate any remaining cancer cells after recovery [28]. Normal cells can regulate their natural alkalinity and excrete excess pH [29, 30]. This could be a significant development in chemotherapy, with fewer side effects than conventional drugs. Further research is required. Ethical approval will apply to ethical committee at Mansoura university faculty of medicine
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Alkaline Glucosodiene Molecules
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkaline Glucosodiene MoleculesDrug
Toxic chemotherapeutic nutrition of cancer cells by alkaline glucosodiene molecules via targeting metabolic of cancerous tumors: a promising treatment
| Study group | Role | What they receive |
|---|---|---|
| a case study with TNBC or ER positive , PR positive HER2 negative , | Experimental | researchers will study a case with metastatic breast cancer stage 4 and the source of nutrition either glucose source as energy fuel of cells or another nutrition ( alkaline glucosodiene) Receives: Drug: Alkaline Glucosodiene Molecules |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Progression-free survival (PFS)
the time from treatment initiation until disease progression or worsening may be used as a direct or surrogate measure of clinical benefit for drug approvals, depending on the disease and response observed
Measured: Time Frame: 30 days after treatment
Disease-free survival (DFS)
time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.
Measured: Time Frame: 30 days after treatment
Secondary outcomes (1)
the change in tumor size or fungating wound at the original site of tumor
researchers will register the changes either improvement or progression at the original wound after mastectomy and overall symptoms of metastatic patient like headache, body aches, vomiting , gaspings , salty taste
Measured: Time Frame: 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a case study
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Collaborators
- Maher M.akl
- Responsible party
- Principal investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957939
- Sponsor's protocol ID
- Maher M.Akl, Amr Ahmed
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Triple-negative Breast Cancer or ER-positive, PR Positive her2 Negative by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT05957939
- Acronym / sponsor ID
- Maher M.Akl, Amr Ahmed
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Collaborators
- Maher M.akl
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jul 2023 (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.
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of estrogen, progesterone, and human epidermal growth factor receptors TNBC makes up almost 15% of all invasive breast cancers, and of all breast tumor subtypes, it has the worst overall survival and the highest rate of metastatic occurrence. Cytotoxic chemotherapy is the main established systemic therapy for early and advanced TNBC disease at the moment because there is no authorized targeted therapy. Despite the fact that chemotherapy greatly improves clinical outcomes for TNBC patients, recurrence rates are still high and TNBC cancers frequently develop chemotherapeutic drug resistance ). In light of the few available therapy choices, so few choices for this subtype of breast cancer, and many cases are resistant to chemotherapy and recurrent and with a risk of high metastasis from previous literature and many experimental studies, the target of glucose environment is a promising weapon against this deadly type of breast cancer so glucose deprivation from tumor cells may cut the glucose entry as fuel to these cancer cells so this study uses a substitute energy fuel by using alkaline glucosodiene which is chemically invented by Maher M.AKL
Detailed description
Breast cancer is the most frequently diagnosed and the second largest cause of cancer-related deaths in women aged 29 to 59 worldwide[1-4]. It is a genetically heterogeneous illness. Breast cancer treatments available today may help increase patient survival. However, one-third of patients with aggressive triple-negative breast cancer (TNBC), which accounts for 17-20 percent of all breast cancers [5-7], may experience more relapses than patients with subtypes of breast cancer that express receptors for the hormones estrogen (ER), progesterone (PR), or human epidermal growth factor (HER-2). The 17-20 percent of TNBC patients who experience this eventually pass away from a distant metastatic disease[5, 8-10]. Although decades of research have improved our understanding of the issue, the pathobiology of breast cancer progression's basic mechanisms remain a mystery.Cancer is a genetic disease characterized by heritable defects in cellular regulatory mechanisms. Tumor cells must adapt their metabolism to survive and proliferate in the challenging conditions of the tumor microenvironment. To maintain uncontrolled cellular growth and survival, cancer cells alter their metabolism, which makes them dependent on a steady supply of nutrients and energy. Almost a century ago, the Warburg theory suggested that cancer cells consume glucose even in the presence of oxygen. Recent studies have confirmed that cancer cells indeed consume significantly more glucose than normal cells. Cancerous tumors require an acidic microenvironment with low oxygen levels for growth and spread. However, recent advances in pH measurement have shown that the intracellular pH of cancer cells is neutral or slightly alkaline compared to normal tissue cells. This finding indicates that not all tumors are highly acidic. Taking advantage of cancer cells' high glucose consumption, a strategy to lyse cancer cells is tested by means of glucose modifications that exploit the characteristics of their uncontrolled growth process.
From the study of the molecular structure to give him alkaline properties that enable him to make defects in the tumor structure and possibly achieve cell killing, this situation will have a killing effect on cancer cells if small molecules of toxic atoms (alkaline atoms) can be continuously supplied to them through food, due to the uncontrolled consumption of glucose molecules by cancer cells. This theory attempts to investigate by changing the atomic structure of glucose molecules to make them alkaline glucosodiene molecules as one of the methods to kill cancer cells. By preparing alkaline glucosodiene molecules and performing animal experiments and histological observations, it was shown that tumors without alkaline treatment showed a tendency to infiltrate and grow, while tumors treated with glucosodiene molecules showed complete disappearance of cell structure and nucleolysis, supporting the validity of the theory. Cancer cells are known to be more sensitive to heat and apoptosis than normal cells, and this property has been leveraged to develop glucosodiene molecules that induce tumor hyperthermia. The chemical mechanism of sodium processing in this approach is similar to the cathode reaction in electrochemotherapy. Cancer cells take up glucosodiene because they are capable of growing uncontrollably and lack the sophisticated brain function necessary to distinguish between glucose and modified glucose. Glucosodiene kills cancer cells by breaking down glucose molecules into carbon dioxide and water, generating energy that alkali elements utilize to dissolve cancer cells from within. This approach is effective for treating numerous types of cancer due to the uncontrolled development of cancer cells. The traditional approach of eliminating cancer cells is not applicable in this theory, as cancer cells are dissolved from within due to their uncontrollable consumption of glucose molecules. Cancer cells have an uncontrolled ability to multiply and consume glucose molecules. Glucosodiene molecules have been developed to exploit this characteristic by inducing tumor hyperthermia, which makes cancer cells more sensitive to heat and apoptosis. Glucosodiene breaks down glucose molecules into carbon dioxide and water, generating energy that is utilized by alkali elements to dissolve cancer cells from within. Cancer cells that consume sodium-laced glucose struggle to retain their rigid cell structure and instead disintegrate and dissolve into the bloodstream before being excreted as urine. This approach is particularly effective in treating numerous types of cancer because cancer cells predominantly grow in lumped form, allowing for a the localized concentration of alkali elements. so this clinical trial uses case with TNBC ( ) and studies the environment of the tumor at many different environments like high glucose, zinc, insulin, interleukin -6 .
Glucosodiene may hasten the death of aging cells, which resist elimination. The breakdown of sugar molecules without oxygen causes acid, but discomfort subsides when cells take up glucosodiene. The body's T cells eliminate any remaining cancer cells after recovery [28]. Normal cells can regulate their natural alkalinity and excrete excess pH [29, 30]. This could be a significant development in chemotherapy, with fewer side effects than conventional drugs. Further research is required. Ethical approval will apply to ethical committee at Mansoura university faculty of medicine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a case study
| Arm | Type | Receives |
|---|---|---|
| a case study with TNBC or ER positive , PR positive HER2 negative , | Experimental | Drug: Alkaline Glucosodiene Moleculesresearchers will study a case with metastatic breast cancer stage 4 and the source of nutrition either glucose source as energy fuel of cells or another nutrition ( alkaline glucosodiene) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type of patient: Female patient
- Age: 18-55 years
- Type of breast cancer: metastatic breast cancer hormonal or triple-negative breast cancer
Key exclusion criteria (3 listed)
- with other co-morbidities like diabetes or hypertension
- with other type of cancers
- on other chemotherapy or immunotherapy or hormonal therapy
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 |
|---|---|---|
| Alkaline Glucosodiene MoleculesToxic chemotherapeutic nutrition of cancer cells by alkaline glucosodiene molecules via targeting metabolic of cancerous tumors: a promising treatment | Drug | a case study with TNBC or ER positive , PR positive HER2 negative , |
Primary outcome
the Progression-free survival (PFS)
Time frame: Time Frame: 30 days after treatment
the time from treatment initiation until disease progression or worsening may be used as a direct or surrogate measure of clinical benefit for drug approvals, depending on the disease and response observed
Disease-free survival (DFS)
Time frame: Time Frame: 30 days after treatment
time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.
1 secondary outcome
the change in tumor size or fungating wound at the original site of tumor
Time frame: Time Frame: 30 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alkaline Glucosodiene Molecules in people with TNBC - Triple-Negative Breast Cancer, run by Ministry of Health, Saudi Arabia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
the Progression-free survival (PFS) (time frame: Time Frame: 30 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.