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

University of Kansas

Status and phase: Enrolling; Phase 2

Conditions: Colon Adenocarcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06017141

P30CA168524 (U.S. NIH Grant/Contract)

NCI-2023-05587 (Other Identifier)

IIT-2022-VIVA (Other Identifier)

STUDY00149314 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer surgery.

SECONDARY OBJECTIVES:

I. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on patient reported post-operative recovery:

Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of Recovery Score [QoR]-40) on the day of discharge and other post-operative timepoints; Ib. Changes in overall and domain-specific post-operative recovery over time.

II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record (EMR), including:

IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI) function (from medical record); IId. Post-operative cognitive impairment (from medical record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from medical record); IIg. Overall survival (from medical record). III. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of inflammatory cytokines, immune cell populations, global inflammatory markers.

IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to standard of care practices of the University of Kansas Medical Center (KUMC) Division of Medical Oncology GI oncology practice.

V. Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular traps (NET) levels, measures of immune suppression, ctDNA.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive sedation with propofol IV prior to surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

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

After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks, 3 and 6 months, and then yearly for 5 years from SOC surgery.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Arm I (sevoflurane, fentanyl citrate, propofol)

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical Procedure

Drug: Sevoflurane

Other: Electronic Health Record Review

Drug: Propofol

Drug: Fentanyl Citrate

Procedure: Biospecimen Collection

Other: Questionnaire Administration

Arm II (fentanyl citrate, propofol)

Experimental group

Description:

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.

Treatment:

Procedure: Surgical Procedure

Other: Electronic Health Record Review

Drug: Propofol

Drug: Fentanyl Citrate

Procedure: Biospecimen Collection

Other: Questionnaire Administration