Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study

NCT06017141 | Recruiting Phase 2 DMC

• 4 other identifiers: STUDY00149314NCI-2023-05587IIT-2022-VIVAP30CA168524
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.

Conditions

Colon Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Neutrophil extracellular traps (NET) formation

  The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.

  Post-operative day (POD) 1 to POD 6 months

Secondary Outcomes (13)

• Early post-operative recovery

  Post-Operative Day 0 to post-operative discharge, approximately 2-4 days

• Global and post-operative recovery

  Post-Operative Day 0 to 6 months post-operatively

• Post-operative nausea scores

  Post-Operative Day 0 to post-operative discharge, approximately 2-4 days

• Number and cumulative amount of doses of anti-emetics

  Post-Operative Day 0 to post-operative discharge, approximately 2-4 days

• Total hospital opioid use

  Post-Operative Day 0 to post-operative discharge, approximately 2-4 days

Study Arms (2)

Arm I (sevoflurane, fentanyl citrate, propofol)

ACTIVE COMPARATOR

Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Fentanyl Citrate; Drug: Propofol; Other: Questionnaire Administration; Drug: Sevoflurane; Procedure: Surgical Procedure

Arm II (fentanyl citrate, propofol)

EXPERIMENTAL

Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Fentanyl Citrate; Drug: Propofol; Other: Questionnaire Administration; Procedure: Surgical Procedure

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Fentanyl Citrate DRUG

Given via injection

Also known as: Actiq, Fentanyl, Fentyl, Oralet, Sublimaze

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Propofol DRUG

Given IV

Also known as: Diprivan

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Questionnaire Administration OTHER

Ancillary studies

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Sevoflurane DRUG

Given via inhalation

Also known as: Ultane

Arm I (sevoflurane, fentanyl citrate, propofol)

Surgical Procedure PROCEDURE

Undergo SOC surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Arm I (sevoflurane, fentanyl citrate, propofol); Arm II (fentanyl citrate, propofol)

Eligibility Criteria

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

You may qualify if:

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males and females age \>= 18 years on day of consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Patients undergoing resection for biopsy proven colon adenocarcinoma
• Medically fit for colon resection
• Ability to complete required study questionnaires
• Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

• Diagnosis of rectal adenocarcinoma
• Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial eligibility for subsequent studies will be determined by the VIVA principal investigator (PI) and the PI of the other clinical trial in question
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Active grade 3 (per the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
• Prisoner status
• Allergies to eggs, egg products, soybeans, or soy products (relative or absolute contraindication to propofol)
• Personal or first degree relative with a history of malignant hyperthermia (absolute contraindication to inhaled volatile anesthetics)
• Diagnosis of inflammatory bowel disease
• Planned multi-visceral resection (examples include: pelvic exenteration, combined liver and colon resection)
• Patients undergoing resection for unresectable polyps, or incomplete polypectomies without biopsy proven adenocarcinoma are excluded

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Specimen Handling; Fentanyl; Propofol; Sevoflurane; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Luke V Selby

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and statisticians are blinded to the type of anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 30, 2023
• Study Start: May 22, 2023
• Primary Completion: May 22, 2025
• Study Completion (Estimated): May 22, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

US (1)