RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

VIVA: Volatile or IV Anesthesia for Cancer

Quick Facts

Study Start:2023-05-22

Study Completion:2026-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06017141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Luke V Selby

PRINCIPAL_INVESTIGATOR

University of Kansas

Study Locations (Sites)

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Luke V Selby, PRINCIPAL_INVESTIGATOR, University of Kansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-22

Study Completion Date2026-05-22

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2026-05-22

Terms related to this study

Additional Relevant MeSH Terms

Colon Adenocarcinoma