Clinical trial · Interventional
Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
VIVA: Volatile or IV Anesthesia for Cancer
NCT06017141CI-TRIAL-00069200unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Fentanyl Citrate | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Sevoflurane | Drug | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (sevoflurane, fentanyl citrate, propofol)
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Drug: Fentanyl Citrate
- Drug: Propofol
- Other: Questionnaire Administration
- Drug: Sevoflurane
- Procedure: Surgical Procedure
- type
- EXPERIMENTAL
- label
- Arm II (fentanyl citrate, propofol)
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.