Clinical trial NCT06017141: Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
Official title: VIVA: Volatile or IV Anesthesia for Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colon Adenocarcinoma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neutrophil extracellular traps (NET) formation
timeFrame: Post-operative day (POD) 1 to POD 6 months
Secondary outcomes:
measure: Early post-operative recovery
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Global and post-operative recovery
timeFrame: Post-Operative Day 0 to 6 months post-operatively
measure: Post-operative nausea scores
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Number and cumulative amount of doses of anti-emetics
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Total hospital opioid use
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Patient-reported pain scores
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Number of times a pro re nata (PRN) medication administered
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)
timeFrame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
measure: Time from study entry and from surgery to disease recurrence, death, or loss to follow up
timeFrame: Post-Operative Day 0 up to Five Years Post-Operation
measure: Post-operative complications
timeFrame: Post-Operative Day 0 to Three Months Post-Operatively
measure: Post-operative immune suppression
timeFrame: Post-Operative Day 1 to 6 months Post-Operatively
measure: Circulating tumor deoxyribonucleic acid (ctDNA)
timeFrame: Post-Operative Day 0 up to 5 years
measure: Changes in gene expression
timeFrame: Immediately post-operatively
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: University of Kansas
name: Luke V Selby
role: PRINCIPAL_INVESTIGATOR
References: