AnesthesiaNCT04962672
Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study
A study testing Propofol group and Sevoflurane group in people with Anesthesia and Brain Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Brain Cancer, Survival
- What is being tested?
- Propofol group and Sevoflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting between Jul 1, 2022 and Dec 28, 2023 for elective procedure
- Males or females of >18 years
- Patient will be undergoing primary craniotomy (with general anesthesia) for suspected high-grade primary glial brain tumor (WHO grade III and IV)
Who cannot join
- Patients of pediatric age group and pregnant patients
- Patients previously diagnosed with severe adrenal dysfunction (over activity or insufficiency)
- 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)
- Awake craniotomies
- Any conditions that preclude postoperative MRI
- Motor evoked potential monitoring or any other intraoperative condition that renders choice of anesthetics affected.
- Recurrent GBM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital/UHN
Toronto, Ontario, M5T 2S8
Emad Al Azazi, MD, 4166035800 ext. 2508, emad.alazazi@uhnresearch.ca
About this study
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.
Read the detailed description
In Canada, cancer is the most common cause of death. Among solid organ cancers, brain tumors, depending upon type and grading, impose significant morbidity and mortality. In addition, cancer progression and recurrence is one of the most common complications in management of high-grade gliomas and among all, Glioblastoma Multiforme (GBM) is the most common and aggressive primary brain cancer. Many factors have been demonstrated to affect glioma progression . Some of the most consistently sited variables are age, grade of tumor, tumor size and location, molecular diagnosis, extent of resection, and chemotherapy and radiotherapy.
On the other hand, though, anesthesia remains an integral part of glioma surgeries, and two types of anesthetics (total intravenous agent, such as, propofol and volatile, such as sevoflurane) are commonly used during maintenance phase of general anesthesia (GA) across over all world; their effects on brain cancer progression are not yet investigated extensively. Recent studies have highlighted that there could be an association of anesthesia with cancer progression in other solid organs. Very few researches have been published demonstrating the relationship between type of anesthetic and glioma progression. One study found that exposure of glioblastoma stem cells to volatile agent (isoflurane) increased their migration capacity in vitro and increased their migration distance in vivo in animals. A second study found that exposure of glioma stem cells to sevoflurane increased tumor cell proliferation as well as tumor markers, most notably hypoxia-inducible factors (HIF), which are associated with cancer growth. Finally, a retrospective cohort study published in 2019 compared the progression free survival (PFS) of patients who underwent high-grade glioma surgery using two different types of anesthetics. They found that, for patients with low KPS, anesthesia maintenance with propofol yielded a longer PFS compared to sevoflurane (15). With this background, it seems propofol based anesthesia may limit the progression of brain cancer progression and therefore, the purpose is to evaluate type of anesthetics (propofol versus sevoflurane) as a factor responsible for glioma progression and survival characteristics. As the Investigators are planning for a future phase III study, it is imperative to understand thoroughly the details regarding feasibility, workflow, enrollment and drop out characteristics, reasons of deviation and adherence rates to anesthesia protocols and problems in follow ups. Therefore, this feasibility study is a path to a well-designed larger multicenter randomized study.
- Conditions
- Anesthesia, Brain Cancer, Survival
- Being tested
- Propofol group, Sevoflurane group
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupDrug
Also called Total intravenous anesthesia
20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.
Sevoflurane groupDrug
Also called Volatile anesthesia
20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | 20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. Receives: Drug: Propofol group |
| Sevoflurane group | Active comparator | 20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group will received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. Receives: Drug: Sevoflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Feasibility outcomes: successful recruitment of trial participants
Measured: 6 months
retention rate
Feasibility outcomes: successful retention of trial participants
Measured: 6 months
rate of protocol adherence
Feasibility outcomes: successful intervention fidelity, identification of barriers to implementation of the intervention, and the feasibility of collecting outcome assessment data.
Measured: 6 months
Secondary outcomes (2)
Overall survival
The following details will be monitored
- date of detection of first progression,
- after surgery radiotherapy (start day after surgery, dose, fractions),
- after surgery chemotherapy (start date after surgery, number of cycles),
- date of the last follow-up
Measured: 6 months
Progression free survival
- date of detection of first progression,
- after surgery radiotherapy (start day after surgery, dose, fractions),
- after surgery chemotherapy (start date after surgery, number of cycles),
- date of the last follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tumul Chowdhury, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962672
- Sponsor's protocol ID
- 21-5527.0
- Status last verified
- Jan 2025
- First submitted
- 19 May 2021
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study
- ClinicalTrials.gov ID
- NCT04962672
- Acronym / sponsor ID
- 21-5527.0
- Conditions
- Anesthesia, Brain Cancer, Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 15 Jul 2021 (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.
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.
Detailed description
In Canada, cancer is the most common cause of death. Among solid organ cancers, brain tumors, depending upon type and grading, impose significant morbidity and mortality. In addition, cancer progression and recurrence is one of the most common complications in management of high-grade gliomas and among all, Glioblastoma Multiforme (GBM) is the most common and aggressive primary brain cancer. Many factors have been demonstrated to affect glioma progression . Some of the most consistently sited variables are age, grade of tumor, tumor size and location, molecular diagnosis, extent of resection, and chemotherapy and radiotherapy.
On the other hand, though, anesthesia remains an integral part of glioma surgeries, and two types of anesthetics (total intravenous agent, such as, propofol and volatile, such as sevoflurane) are commonly used during maintenance phase of general anesthesia (GA) across over all world; their effects on brain cancer progression are not yet investigated extensively. Recent studies have highlighted that there could be an association of anesthesia with cancer progression in other solid organs. Very few researches have been published demonstrating the relationship between type of anesthetic and glioma progression. One study found that exposure of glioblastoma stem cells to volatile agent (isoflurane) increased their migration capacity in vitro and increased their migration distance in vivo in animals. A second study found that exposure of glioma stem cells to sevoflurane increased tumor cell proliferation as well as tumor markers, most notably hypoxia-inducible factors (HIF), which are associated with cancer growth. Finally, a retrospective cohort study published in 2019 compared the progression free survival (PFS) of patients who underwent high-grade glioma surgery using two different types of anesthetics. They found that, for patients with low KPS, anesthesia maintenance with propofol yielded a longer PFS compared to sevoflurane (15). With this background, it seems propofol based anesthesia may limit the progression of brain cancer progression and therefore, the purpose is to evaluate type of anesthetics (propofol versus sevoflurane) as a factor responsible for glioma progression and survival characteristics. As the Investigators are planning for a future phase III study, it is imperative to understand thoroughly the details regarding feasibility, workflow, enrollment and drop out characteristics, reasons of deviation and adherence rates to anesthesia protocols and problems in follow ups. Therefore, this feasibility study is a path to a well-designed larger multicenter randomized study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofol group20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. |
| Sevoflurane group | Active comparator | Drug: Sevoflurane group20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group will received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient presenting between Jul 1, 2022 and Dec 28, 2023 for elective procedure
- Males or females of >18 years
- Patient will be undergoing primary craniotomy (with general anesthesia) for suspected high-grade primary glial brain tumor (WHO grade III and IV)
Key exclusion criteria (7 listed)
- Patients of pediatric age group and pregnant patients
- Patients previously diagnosed with severe adrenal dysfunction (over activity or insufficiency)
- 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)
- Awake craniotomies
- Any conditions that preclude postoperative MRI
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 |
|---|---|---|
| Propofol groupAlso: Total intravenous anesthesia20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg. | Drug | Propofol group |
| Sevoflurane groupAlso: Volatile anesthesia20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg. | Drug | Sevoflurane group |
Primary outcome
Rate of recruitment
Time frame: 6 months
Feasibility outcomes: successful recruitment of trial participants
retention rate
Time frame: 6 months
Feasibility outcomes: successful retention of trial participants
rate of protocol adherence
Time frame: 6 months
Feasibility outcomes: successful intervention fidelity, identification of barriers to implementation of the intervention, and the feasibility of collecting outcome assessment data.
2 secondary outcomes
Overall survival
Time frame: 6 months
Progression free survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
Tumul Chowdhury, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol group and Sevoflurane group in people with Anesthesia and Brain Cancer, run by University Health Network, Toronto 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emad Al Azazi, MD (416-603-5800 ext. 2508, emad.alazazi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: 6 months). 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?
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 31 Jan 2025.