Anesthesia and Cancer Recurrence im Malignant Melanoma

December 10, 2014 updated by: University Hospital Muenster

Long-term Outcome After Radical Lymph Node Dissection of Malignant Melanoma. Comparison Between Regional Versus General Anesthesia With Respect to Impact of Perioperative Immunoediting and Validation of New Potential Predictive Biomarkers

Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.

The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gerhard Brodner, Prof. Dr.
  • Phone Number: +49-251-3287-0

Study Locations

  • Germany
      • Münster, Germany, D-48157
        • Recruiting
        • Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
        • Contact:
          • Gerhard Brodner, MD PhD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
  • Signed informed consent

Exclusion Criteria:

  • Age < 18 years
  • Female patients who are pregnant or nursing
  • Multiple organ failure
  • Contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General anesthesia
Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Other Names:
  • General anesthesia
Experimental: Regional anesthesia
Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Other Names:
  • Regional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the total amount of immune cells
Time Frame: 15 minutes before end of surgery
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgery
15 minutes before end of surgery
Changes of the total amount of immune cells
Time Frame: 24 hours postoperatively
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively
24 hours postoperatively
Changes of the total amount of immune cells
Time Frame: Five days postoperatively
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively
Five days postoperatively
Potential predictive biomarkers
Time Frame: 15 minutes before end of surgery
Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
15 minutes before end of surgery
Potential predictive biomarkers
Time Frame: 24 hours postoperatively
Change of potential predictive biomarkers from baseline until 24 hours postoperatively
24 hours postoperatively
Potential predictive biomarkers
Time Frame: Five days postoperatively
Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
Five days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Study Chair: Hugo K Van Aken, MD PhD, University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy

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 Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-AnIt-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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