Trial Title:
Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
NCT ID:
NCT06017141
Condition:
Colon Adenocarcinoma
Conditions: Official terms:
Colonic Neoplasms
Fentanyl
Propofol
Sevoflurane
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Patients and statisticians are blinded to the type of anesthesia.
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and tissue sample collection
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Intervention type:
Drug
Intervention name:
Fentanyl Citrate
Description:
Given via injection
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Other name:
Actiq
Other name:
Fentanyl
Other name:
Fentyl
Other name:
Oralet
Other name:
Sublimaze
Intervention type:
Drug
Intervention name:
Propofol
Description:
Given IV
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Other name:
Diprivan
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Intervention type:
Drug
Intervention name:
Sevoflurane
Description:
Given via inhalation
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Other name:
Ultane
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo SOC surgery
Arm group label:
Arm I (sevoflurane, fentanyl citrate, propofol)
Arm group label:
Arm II (fentanyl citrate, propofol)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, NOS
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke V. Selby
Phone:
913-588-7750
Email:
lselby@kumc.edu
Investigator:
Last name:
Luke V. Selby
Email:
Principal Investigator
Start date:
May 22, 2023
Completion date:
May 22, 2026
Lead sponsor:
Agency:
University of Kansas Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Kansas Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06017141
