Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study

NCT04962672 | Recruiting

• 1 other identifier: 21-5527.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Brain Cancer; Survival

Outcome Measures

Primary Outcomes (3)

• Rate of recruitment

  Feasibility outcomes: successful recruitment of trial participants

  6 months

• retention rate

  Feasibility outcomes: successful retention of trial participants

  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.

  6 months

Secondary Outcomes (2)

• Overall survival

  6 months

• Progression free survival

  6 months

Study Arms (2)

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.

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.

Drug: Sevoflurane group

Interventions

Propofol group DRUG

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.

Also known as: Total intravenous anesthesia

Propofol group

Sevoflurane group DRUG

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.

Also known as: Volatile anesthesia

Sevoflurane group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital/UHN

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tumul Chowdhury, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emad Al Azazi, MD

CONTACT

416-603-5800; emad.alazazi@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: July 15, 2021
• Study Start: January 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: September 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)