NCT04962672 Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study
| NCT ID | NCT04962672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2025-07-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Cancer is a leading cause of death worldwide. It is estimated that approximately 55,000 Canadians are surviving with brain tumors. It is projected that around 3000 persons will be diagnosed with brain and spinal cord tumors, and approximately 75 percent patients will not survive. Out of all brain cancers, high-grade gliomas \[Glioblastoma Multiforme (GBM)\] impose highest morbidity and mortality. Therefore, it is important to explore ways in which Investigators can improve and prolong the lives of patients suffering from brain cancers, particularly high-grade glioma, which is the most common and aggressive primary brain tumor. So far the Investigators know that the surgery, chemotherapy and radiotherapy are the three corner stones management options for these patients, and majority of the research have been conducted on these three major domains. Therefore, it is imperative to explore the other variables those may impact survival characteristics. One of the integral variables of the brain cancer surgery is anesthesia. Interestingly, the role of anesthetics was explored in some other non-brain solid organ tumor surgeries. It is observed that out of the two main types of anesthesia \[one is through intravenous (propofol) and other one is gaseous (sevoflurane)\], intravenous based anesthesia maintenance regime may delay the cancer progression and prolong the recurrence free period. In addition, two very large retrospective studies with approximately 11,000 and 18,000 patients respectively, showed that as compared to gaseous (volatile anesthetics) based, intravenous (propofol) based anesthesia conferred some protection against cancer progression and was also associated with lesser overall mortality. The exact nature of these protective mechanisms is not known but in animal and other laboratory-based experiments, propofol seems to inhibit cancer formation steps, delays inflammation and provide protection from cancer cell growth. This is a feasibility study for knowing various aspects of workflow; recruitment characteristics of participants and various obstacles in implying anesthesia based protocols so that the Investigators can conduct a well-designed multicenter international randomized study.
Eligibility Criteria
Inclusion Criteria: 1. Patient presenting between Jul 1, 2022 and Dec 28, 2023 for elective procedure 2. Males or females of \>18 years 3. Patient will be undergoing primary craniotomy (with general anesthesia) for suspected high-grade primary glial brain tumor (WHO grade III and IV) Exclusion Criteria: 1. Patients of pediatric age group and pregnant patients 2. Patients previously diagnosed with severe adrenal dysfunction (over activity or insufficiency) 3. Suspected low grade (grade I, II), glioma, tumors involving brainstem and optic tract, and as well as non-glial tumors (i.e. suspected brain metastasis) 4. Awake craniotomies 5. Any conditions that preclude postoperative MRI 6. Motor evoked potential monitoring or any other intraoperative condition that renders choice of anesthetics affected. 7. Recurrent GBM