Cancer Mortality Affected by the Choice of Anesthetic Drugs?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enlund, Uppsala University
ClinicalTrials.gov Identifier:
NCT01418326
First received: May 12, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?

Aim: To retrospectively examine possible associations (Cox Multiple Regression) between survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during surgery, ahead of a prospective randomised controlled trial.

Hypotheses: One- and five-year survival will be significantly higher after radical breast-, colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.

Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical data from 6 303 patients operated on at the three mentioned anatomical locations at the Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these minimum 4 500 operations would be due to cancer. This register is unique, in that it contains both types of anaesthesia. The other register holds survival data (date and cause of death), stored at the Regional Oncologic Center in Uppsala.

The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper file, concomitantly with extraction of details from anaesthesia and surgery, such as the functional classification of each patient (according to American Association of Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss and possible transfusion.

Current knowledge: Different anaesthetics have opposite effects on the immune system and on the DNA. There is a well-established association between the state of the immune system and cancer growth, which in turn will influence survival. There is also an association between DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and anti-oxidative, and it is not genotoxic.

Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in advance of a multi-centre, prospective, randomised, controlled trial.

Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired effects from anaesthesia on survival has strong relevance for the over all cancer treatment.


Condition
Breast Cancer
Colo-rectal Cancer
Skin Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cancer Mortality Affected by the Choice of Anesthetic Drugs?

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Survival [ Time Frame: One year from index procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Five years from index procedure ] [ Designated as safety issue: No ]

Enrollment: 3284
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sevoflurane
Sevoflurane exposure for radical cancer surgery
Propofol
Propofol exposure for cancer surgery

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients operated on for cancer in breast, colo-rectally, or in skin at a single institution from Jan 1, 1998 to Dec 31, 2009.

Criteria

Inclusion Criteria:

  • Exposed to general anesthesia for surgical removal of cancer in breast, colo-rectally, or in skin

Exclusion Criteria:

  • Paper file unable to find or missing data in anesthetic file or in outcome registry
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418326

Locations
Sweden
Uppsala University, Centre for Clinical Research-Vasteras
Vasteras, Sweden, SE-72189
Sponsors and Collaborators
Enlund
Investigators
Principal Investigator: Mats Enlund, M.D., Ph.D. Uppsala University, Centre for Clinical Research-Vasteras
Study Director: Leif Bergkvist, M.D., Ph.D. Uppsala University, Centre for Clinnical Research-Vasteras
Study Chair: Mats Lambe, M.D., Ph.D. Uppsala University, Regional Oncologic Centre
  More Information

No publications provided

Responsible Party: Enlund, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01418326     History of Changes
Other Study ID Numbers: 2008350
Study First Received: May 12, 2011
Last Updated: February 3, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
Cancer - breast
colo-rectal
skin

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Skin Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014