We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anesthesia and Cancer Recurrence im Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01588847
Recruitment Status : Recruiting
First Posted : May 1, 2012
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:

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 or disease Intervention/treatment
Malignant Melanoma Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 % Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

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  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Melanoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Overall survival [ Time Frame: five years ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Potential predictive biomarkers [ Time Frame: 24 hours postoperatively ]
    Change of potential predictive biomarkers from baseline until 24 hours postoperatively

  6. Potential predictive biomarkers [ Time Frame: Five days postoperatively ]
    Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01588847     History of Changes
Other Study ID Numbers: 02-AnIt-11
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

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

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