Malignant MelanomaNCT01588847
Anesthesia and Cancer Recurrence im Malignant Melanoma
A study testing Spinal anesthesia with Bupivacaine hyperbar 0.5 % and General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane in people with Malignant Melanoma, run by University Hospital Muenster at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Spinal anesthesia with Bupivacaine hyperbar 0.5 % and General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
- Signed informed consent
Who cannot join
- Age < 18 years
- Female patients who are pregnant or nursing
- Multiple organ failure
- Contraindications
Trial locations and contacts
1 site in 1 country.
Gerhard Brodner, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
Münster, D-48157
Gerhard Brodner, MD PhD
About this study
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
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.
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- Spinal anesthesia with Bupivacaine hyperbar 0.5 %, General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
- Keywords
- perioperative immunoediting, potential predictive biomarkers, lymph node dissection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with Bupivacaine hyperbar 0.5 %Procedure or surgery
Also called Regional anesthesia
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
General anesthesia with Sufentanil, Propofol and Rocuronium and SevofluraneProcedure or surgery
Also called General anesthesia
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia | Experimental | Not described Receives: Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 % |
| General anesthesia | Active comparator | Not described Receives: Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: five years
Secondary outcomes (6)
Changes of the total amount of immune cells
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
Measured: 15 minutes before end of surgery
Changes of the total amount of immune cells
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
Measured: 24 hours postoperatively
Changes of the total amount of immune cells
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
Measured: Five days postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
Measured: 15 minutes before end of surgery
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 24 hours postoperatively
Measured: 24 hours postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
Measured: Five days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo K Van Aken, MD PhD, Study chair, University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588847
- Sponsor's protocol ID
- 02-AnIt-11
- Status last verified
- Dec 2014
- First submitted
- 13 Mar 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01588847
- Acronym / sponsor ID
- 02-AnIt-11
- Conditions
- Malignant Melanoma
- Keywords
- perioperative immunoediting, potential predictive biomarkers, lymph node dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | Experimental | Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 % |
| General anesthesia | Active comparator | Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
- Signed informed consent
Key exclusion criteria (4 listed)
- Age < 18 years
- Female patients who are pregnant or nursing
- Multiple organ failure
- Contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia with Bupivacaine hyperbar 0.5 %Also: Regional anesthesiaSpinal anesthesia with Bupivacaine hyperbar 0.5 % | Procedure or surgery | Regional anesthesia |
| General anesthesia with Sufentanil, Propofol and Rocuronium and SevofluraneAlso: General anesthesiaGeneral anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane | Procedure or surgery | General anesthesia |
Primary outcome
Overall survival
Time frame: five years
6 secondary outcomes
Changes of the total amount of immune cells
Time frame: 15 minutes before end of surgery
Changes of the total amount of immune cells
Time frame: 24 hours postoperatively
Changes of the total amount of immune cells
Time frame: Five days postoperatively
Potential predictive biomarkers
Time frame: 15 minutes before end of surgery
Potential predictive biomarkers
Time frame: 24 hours postoperatively
Potential predictive biomarkers
Time frame: Five days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Brodner, Prof. Dr. contact
Hugo K Van Aken, MD PhD study chair
University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia with Bupivacaine hyperbar 0.5 % and General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane in people with Malignant Melanoma, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Brodner, Prof. Dr. (+49-251-3287-0), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.