- What is Targeted Osmotic Lysis (TOL)?
- Targeted Osmotic Lysis (TOL) is a novel cancer treatment approach that selectively targets and destroys cancer cells while sparing healthy cells. It exploits the overexpression of voltage-gated sodium channels (VGSCs) and sodium-potassium pumps in cancer cells, leading to an influx of sodium ions and water, causing the cancer cells to burst due to increased osmotic pressure.
- How does TOL work?
- TOL involves administering a combination of a VGSC activator and a sodium pump inhibitor. The VGSC activator enhances the activity of the overexpressed VGSCs in cancer cells, while the sodium pump inhibitor (typically a cardiac glycoside medication) blocks the sodium-potassium pumps, preventing the extrusion of sodium ions from the cancer cells. This synergistic effect leads to a massive influx of sodium ions and water into the cancer cells, causing them to swell and burst due to the increased osmotic pressure.
- What types of cancer can TOL potentially treat?
- TOL has shown promising results in treating various types of aggressive and metastatic cancers, particularly those that exhibit significant overexpression of VGSCs and sodium pumps. Preclinical studies and initial human case reports have demonstrated the potential of TOL in treating astrocytoma, metastatic pancreatic carcinoma, as well as other advanced disease such as advanced metastatic melanoma, signet cell adenocarcinoma, advanced cervical carcinoma, advanced breast cancer, and advanced oral squamous cell carcinoma and potentially others.
- How does TOL compare to conventional treatments like chemotherapy?
- Unlike chemotherapy and radiation, which indiscriminately attacks both cancerous and healthy cells, TOL is a targeted approach that exploits the unique biological characteristics of cancer cells. By selectively destroying cells that overexpress VGSCs and sodium pumps, TOL minimizes collateral damage to normal tissues, significantly reducing the risk of severe side effects associated with chemotherapy or radiation. Additionally, TOL has shown promise in treating aggressive or metastatic cancers that may be resistant to standard treatments.
- What are the potential benefits of TOL?
- The potential benefits of TOL include:
- Reduction in tumor size or growth rate.
- Improvement in metastatic lesions.
- No significant adverse effects in treated cases.
- Selective targeting of cancer cells, minimizing damage to healthy tissues.
- Reduced risk of severe side effects commonly associated with chemotherapy and radiation therapy.
- Improved quality of life during treatment due to fewer side effects.
- Potential for treating advanced or metastatic cancers that are resistant to standard treatments.
- Non-invasive nature, potentially eliminating the need for surgical interventions.
- Potential for use as a standalone treatment or as an adjuvant therapy in combination with other treatments.
- What is the success rate of TOL?
- The success rate of Targeted Osmotic Lysis (TOL) in treating various types of cancer is still being evaluated through ongoing clinical and research studies. As a novel treatment approach, the long-term efficacy and success rates are not yet fully established. However, preliminary results from preclinical studies, companion animal trials, and limited human case reports have shown promising outcomes, including:
- Reduction in tumor size and growth rate in aggressive and metastatic cancers.
- Potential for extending survival in advanced-stage cancers.
- It's important to note that the success rate of TOL may vary depending on factors such as the type and stage of cancer, the individual patient's response to the treatment, and whether TOL is used as a standalone therapy or in combination with other treatments.
- While the initial findings are encouraging, further research and larger-scale clinical trials are necessary to determine the overall success rate and efficacy of TOL across different cancer types and stages. The TOL trial aims to gather more data and evidence to better understand the potential and limitations of this innovative treatment approach.
- How is the TOL treatment administered?
- The TOL treatment involves the administration of two main components: a VGSC activator and a sodium pump inhibitor. The VGSC activator is delivered through low-intensity pulsed electric fields created by the Coaxial Pulsed Electric Field Generator, the TOL treatment device used at CORE, is a custom-built coaxial ring stimulator. It consists of four circular coils surrounding a supported mattress, where the patient lies comfortably, non-restrained, during a 2-hour session. The device delivers a low-intensity pulsed electric field to activate voltage-gated sodium channels (VGSCs) in cancer cells. The sodium pump inhibitor is typically a cardiac glycoside, such as digoxin, which is administered orally or intravenously.
- What are the eligibility criteria for the TOL trial?
- The eligibility criteria for the TOL trial may vary depending on the specific study protocol, but generally, patients with advanced or metastatic carcinomas that have not responded well to standard treatments may be eligible. Factors such as cancer type, stage, previous treatments, overall health status, and willingness to provide informed consent will be considered. Accurate information provided in the patient questionnaire is crucial for determining eligibility.
- What can patients expect during the TOL treatment process?
- Patients enrolled in the TOL trial will undergo a comprehensive evaluation, including medical history, physical examination, and diagnostic tests. If eligible, they will receive the TOL treatment according to the study protocol, which may involve multiple treatment sessions. Regular monitoring and follow-up appointments will be conducted to assess the treatment's effectiveness, manage any potential side effects, and evaluate the patient's overall well-being.
- What are the potential side effects of TOL?
- Based on preclinical studies, companion animal trials, and limited human case reports, TOL has demonstrated a favorable safety profile with minimal to no reported side effects. However, as with any medical treatment, there may be potential risks or side effects that will be thoroughly explained to eligible participants before obtaining informed consent.
- The cardiac glycoside, digoxin, is a long-used heart medication Digoxin, used in TOL, is safe at prescribed doses but carries risks like mild nausea, fatigue, or, rarely, heart rhythm issues if not properly monitored. No adverse effects were reported in our pilot study when dosed correctly under medical supervision at CORE Medical and Surgery Center. Strict adherence to dosing and regular check-ups minimize risks and enhance treatment effectiveness. Digoxin is carefully dosed to avoid risks such as nausea, fatigue, or rare cardiac effects. In our pilot study, no patients reported significant side effects, and many noted improved energy and appetite. To minimize risks, patients are screened for contraindications, monitored during treatment, and must follow prescribed dosing. Consult your doctor to ensure digoxin is safe for you.
- What kind of outcomes can be expected from TOL treatment?
- The expected outcomes of TOL treatment may vary depending on the individual patient's condition and the specific cancer type. Preliminary results from the pilot study and other case reports have shown promising outcomes, such as reduction in tumor size, slowing of tumor growth, and potential improvement of metastatic lesions. However, it is important to note that TOL is still in the early stages of clinical evaluation, and further research is needed to establish its long-term efficacy and safety.
- Can TOL be combined with other treatments?
- There is evidence suggesting that TOL may be effective as a standalone treatment or as an adjuvant therapy, enhancing the effectiveness of certain chemotherapies when used concurrently. However, the optimal treatment regimen and potential combinations are still being explored. Patients should consult with their healthcare team to determine the most appropriate course of action based on their specific circumstances.
- Do I have to stop my daily medicines?
- The medical team will advise you which medicines you can continue to take or others that can interfere in the treatment process.