Anesthesia and Cancer Recurrence im Malignant Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital Muenster
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01588847
First received: March 13, 2012
Last updated: April 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Malignant Melanoma
Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Overall survival [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of the total amount of immune cells [ Time Frame: 15 minutes before end of surgery ] [ Designated as safety issue: No ]
    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

  • Changes of the total amount of immune cells [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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

  • Changes of the total amount of immune cells [ Time Frame: Five days postoperatively ] [ Designated as safety issue: No ]
    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

  • Potential predictive biomarkers [ Time Frame: 15 minutes before end of surgery ] [ Designated as safety issue: No ]
    Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively

  • Potential predictive biomarkers [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Change of potential predictive biomarkers from baseline until 24 hours postoperatively

  • Potential predictive biomarkers [ Time Frame: Five days postoperatively ] [ Designated as safety issue: No ]
    Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively


Estimated Enrollment: 230
Study Start Date: March 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regional anesthesia Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Other Name: Regional anesthesia
Active Comparator: General anesthesia Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Other Name: General anesthesia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588847

Contacts
Contact: Gerhard Brodner, Prof. Dr. +49-251-3287-0

Locations
Germany
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy Recruiting
Münster, Germany, D-48157
Contact: Gerhard Brodner, MD PhD         
Sponsors and Collaborators
University Hospital Muenster
Investigators
Study Chair: Hugo K Van Aken, MD PhD University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01588847     History of Changes
Other Study ID Numbers: 02-AnIt-11
Study First Received: March 13, 2012
Last Updated: April 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
perioperative immunoediting
potential predictive biomarkers
lymph node dissection

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation
Adjuvants, Anesthesia
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Bupivacaine
Propofol
Sevoflurane
Sufentanil
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on August 28, 2014