Anesthesia for Cancer

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen by Bernhard Riedel, MB.ChB

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Peter MacCallum Cancer Centre, Australia

Must not be taking: Antibiotics, Antifungals, Antiretrovirals, Antidepressants

Disqualifiers: Liver disease, Malignant hyperthermia, Metastases, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

VAPOR-C is a randomised study of the impact of IV versus inhaled anaesthesia (propofol versus sevoflurane) and lidocaine versus no lidocaine on duration of disease free survival inpatients with either colorectal or non small cell lung cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that are moderate to strong inhibitors of specific metabolic pathways (CYP1A2 and CYP3A4) at least 72 hours before surgery. This includes some antibiotics, antifungals, antiretrovirals, antidepressants, calcium-channel blockers, and other specific drugs.

How does the drug Propofol differ from Sevoflurane in cancer treatment?

Propofol, an intravenous anesthetic, may have anticancer properties by suppressing cancer cell growth, while Sevoflurane is an inhaled anesthetic commonly used in surgeries. Some studies suggest Propofol might offer better long-term cancer survival benefits compared to Sevoflurane, although this is still under investigation. ^{1 2 3 4 5}

Research Team

Bernhard Riedel, MB.ChB

Principal Investigator

Peter MacCallum Cancer Centre, Australia

Eligibility Criteria

The VAPOR-C trial is for adults with Stage I-III colorectal or non-small cell lung cancer (NSCLC) who are scheduled for elective surgery that will last at least 2 hours and require a hospital stay of 2+ nights. Participants must be able to follow the study plan and have an ASA score of 1-3. Exclusions include weight under 45kg, significant liver disease, recent other cancers, certain drug use, and allergies to trial drugs.

Inclusion Criteria

Patient has an American Society of Anaesthesiologists (ASA) score of 1 to 3

Has provided written informed consent for the trial

I am 18 years old or older.

Exclusion Criteria

I do not have severe liver disease.

I haven't taken specific strong antibiotics, antifungals, antivirals, antidepressants, or other listed drugs in the last 3 days.

Confirmed or suspected allergy to propofol, sevoflurane or intravenous lidocaine

Treatment Details

Interventions

• Lidocaine IV (Local Anaesthetic)
• Propofol (General Anaesthetic)
• Sevoflurane (General Anaesthetic)

Trial Overview This study compares IV anesthesia (propofol) with inhaled anesthesia (sevoflurane), along with the addition or absence of lidocaine. The goal is to see how these different anesthesia methods affect cancer-free survival time after surgery in patients with colorectal or NSCLC.

Participant Groups

Group I: A Active Control 2 Interventions

Sevoflurane + intravenous lidocaine

Group II: B Active Control 1 Intervention

Sevoflurane

Group III: C Active Control 2 Interventions

Propofol TIVA + intravenous lidocaine

Group IV: D Active Control 1 Intervention

Propofol TIVA

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Medical Center Pittsburgh, PA

Cleveland Clinic Cleveland, OH

The University of Texas MD Anderson Cancer Centre Houston, TX

Who Is Running the Clinical Trial?

Peter MacCallum Cancer Centre, Australia

Lead Sponsor

Trials

102

Patients Recruited

23,700+

National Health and Medical Research Council, Australia

Collaborator

Trials

167

Patients Recruited

473,000+

Australian and New Zealand College of Anaesthetists

Collaborator

Trials

6

Patients Recruited

8,600+

Victorian Comprehensive Cancer Centre

Collaborator

Trials

1

Patients Recruited

250+

Findings from Research

Inhalational anesthetics like isoflurane and sevoflurane may suppress the immune system and promote tumor growth, while propofol-based total intravenous anesthesia (TIVA) shows anti-inflammatory and anti-tumor effects, potentially preventing metastasis.

Clinical studies suggest that TIVA is linked to better disease-free intervals and overall survival in cancer patients, especially in more aggressive cancers and longer surgeries, although more rigorous prospective trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Anesthesia Delivered During Tumor Resection and Cancer Survival: a Systematic Review of a Mixed Picture with Constant Themes. Selby, LV., Fernandez-Bustamante, A., Ejaz, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of equipotent doses of propofol and sevoflurane on endoplasmic reticulum stress during breast cancer surgery. Oh, CS., Hong, SW., Park, S., et al.[2023]

In a study of 6305 breast cancer surgery patients, those who received propofol anesthesia had a 5-year survival rate of 91.0%, compared to 81.8% for those who received sevoflurane, suggesting a potential survival advantage for propofol.

The analysis showed varying results depending on the statistical methods used, indicating that while propofol may improve long-term survival, the limitations of retrospective studies must be considered when interpreting these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival after primary breast cancer surgery following propofol or sevoflurane general anesthesia-A retrospective, multicenter, database analysis of 6305 Swedish patients. Enlund, M., Berglund, A., Ahlstrand, R., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General Anesthetics in Cancer Surgery: Can Anesthesiologists Help the Patient with More than a Safe Sleep. Bonvini, JM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini profile of potential anticancer properties of propofol. Song, J., Shen, Y., Zhang, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association Between Anesthesia Delivered During Tumor Resection and Cancer Survival: a Systematic Review of a Mixed Picture with Constant Themes. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of equipotent doses of propofol and sevoflurane on endoplasmic reticulum stress during breast cancer surgery. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Survival after primary breast cancer surgery following propofol or sevoflurane general anesthesia-A retrospective, multicenter, database analysis of 6305 Swedish patients. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

General Anesthetics in Cancer Surgery: Can Anesthesiologists Help the Patient with More than a Safe Sleep. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mini profile of potential anticancer properties of propofol. [2022]