Anesthesia for Cancer

Recruiting at 29 trial locations

Overseen By Kim Coleman, MN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Peter MacCallum Cancer Centre, Australia

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

Disqualifiers: Liver disease, Malignant hyperthermia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

254 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two types of anesthesia, propofol and sevoflurane, affect recovery in individuals with colorectal or non-small cell lung cancer. Researchers aim to determine whether these drugs, with or without lidocaine (a pain reliever), influence the duration of cancer-free survival after surgery. Candidates for this trial include those with stage I-III colorectal cancer or stage I-IIIa non-small cell lung cancer who are scheduled for surgery lasting at least two hours and requiring a hospital stay of two or more nights. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both propofol and sevoflurane are generally safe for people. Propofol, often used during surgeries, is well-tolerated and may even slow cancer growth by affecting tumor cell behavior. When combined with lidocaine, propofol remains safe and can reduce the need for additional anesthesia, as well as lower side effects like drowsiness.

Sevoflurane is also commonly used and considered safe, with no major safety issues reported. Combined with lidocaine, it might help prevent cancer cells from spreading to the lungs. These findings suggest that both treatments are safe for cancer patients, making them suitable options for this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these anesthesia treatments for cancer because they explore how different anesthesia methods might impact cancer outcomes. Propofol, used in Total Intravenous Anesthesia (TIVA), and Sevoflurane are being compared to see if they affect cancer recurrence differently. This trial also investigates the potential benefits of adding intravenous lidocaine, known for its anti-inflammatory properties, which might enhance recovery and reduce cancer growth. Unlike standard anesthetics that primarily focus on pain and consciousness, these treatments could pave the way for anesthesia that also contributes to better long-term cancer outcomes.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will compare different anesthesia regimens for cancer patients. Research suggests that propofol, one of the treatments in this trial, might help cancer patients live longer. Studies have shown that propofol can lead to better outcomes, such as longer survival and a lower chance of cancer spreading after surgery. When combined with lidocaine, propofol is also linked to a reduced risk of cancer recurrence. In contrast, sevoflurane, another treatment option in this trial, has shown mixed results. Some studies indicate it might lead to more cancer spreading compared to propofol. However, the long-term effects of sevoflurane, with or without lidocaine, on cancer outcomes remain uncertain. ^{4 6 7 8 9}

Who Is on the Research Team?

Bernhard Riedel, MB.ChB

Principal Investigator

Peter MacCallum Cancer Centre, Australia

Are You a Good Fit for This Trial?

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

My colorectal cancer or NSCLC is in an early to mid-stage, confirmed by tests or suspected through scans.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Anaesthesia

Participants undergo surgery with either propofol-TIVA or sevoflurane, with or without intravenous lidocaine

During surgery

Post-operative Monitoring

Participants are monitored for post-operative complications and recovery, including safety profile and concomitant medication use

5 days post-surgery

Follow-up

Participants are monitored for disease progression, overall survival, and chronic post-surgical pain

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine IV
• Propofol
• Sevoflurane

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Peter MacCallum Cancer Centre, Australia

Lead Sponsor

Trials

102

Recruited

23,700+

National Health and Medical Research Council, Australia

Collaborator

Trials

167

Recruited

473,000+

Australian and New Zealand College of Anaesthetists

Collaborator

Trials

6

Recruited

8,600+

Victorian Comprehensive Cancer Centre

Collaborator

Trials

1

Recruited

250+

Published Research Related to This Trial

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]

Surgery for cancer can sometimes lead to tumor growth and spread, making the choice of anesthesia during the perioperative period crucial for patient outcomes.

This review focuses on the effects of different anesthetic agents, particularly volatile inhalational agents and propofol, on cancer progression, highlighting the need for more prospective studies to guide best practices in anesthesia for cancer surgeries.

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]

In a study of 53 patients undergoing breast cancer surgery, propofol anesthesia did not cause greater endoplasmic reticulum (ER) stress in cancer cells compared to sevoflurane anesthesia, indicating similar safety profiles regarding ER stress.

Both anesthesia types resulted in comparable levels of CHOP expression in lymphocytes and similar neutrophil-to-lymphocyte ratios, suggesting that the choice of anesthesia may not significantly impact immune response during surgery.

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]

Propofol has demonstrated anticancer properties by promoting apoptosis in certain cancer cell lines, particularly in non-small cell lung carcinoma (A549), where it significantly increased the expression of caspase-3, a key apoptosis biomarker, in a dose-dependent manner.

The effectiveness of propofol in inducing apoptosis appears to be linked to the presence of Kras mutations, specifically in Codon 12, suggesting that cancer cells with this mutation may be more sensitive to propofol's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11252424/

Survival benefits of propofol-based versus inhalational ... The present study is the first comprehensive meta-analysis to demonstrate that propofol-based anesthesia could significantly improve OS and LRRFS in non- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562064/

a nationwide cohort study in South Korea - PMC Propofol-based TIVA is associated with better survival outcomes after major cancer surgeries. Moreover, propofol-based TIVA was beneficial in patients who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01975064

Cancer and Anesthesia: Survival After Radical Surgery Study Overview. The purpose of this study is to determine whether anesthesia maintained with propofol results in better one- and five-year-survival than ...

4. wjgnet.com wjgnet.com/2218-4333/full/v16/i7/104727.htm

Impact of propofol on gastrointestinal cancer outcomes The results suggested propofol inhibited stomach cancer cell growth and promoted apoptosis via overexpressing miR-205 and inhibiting the Yes- ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/06190/propofol_based_total_intravenous_anesthesia.55.aspx

Propofol-based total intravenous anesthesia improves... Our results showed that propofol-based anesthesia improved survival and relatively reduced the risk of distant metastasis compared to desflurane ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8175878/

Anesthetics or anesthetic techniques and cancer surgical ... Several retrospective studies have demonstrated an association between inhalational anesthesia and reduced recurrence-free survival in cancer patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04316013

Study Details | NCT04316013 | Volatile Anaesthesia and ... This trial is designed to test for superiority in disease free survival (DFS) of propofol (total intravenous anaesthesia -TIVA) over sevoflurane (inhalational ...

8. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15354

Volatile anaesthesia and peri‐operative outcomes related to ... Intravenous lidocaine has anti-inflammatory activity [16] and preclinical evidence [17] suggests that lidocaine can reduce tumour growth and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818025002211

Review Effects of intravenous lidocaine on propofol-based ... Intravenous lidocaine is a safe and effective adjunct to propofol sedation in gastrointestinal endoscopy, reducing anaesthetic requirements and sedation-related ...