Regional Anaesthesia and Substance P in Head and Neck Cancer (SPRANC)
Primary Purpose
Head and Neck Cancer
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SPRANC Block group
SPRANC Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients at Charité - Universitaetsmedizin Berlin, Campus Charité Mitte
- Primary diagnosis of unilateral head or neck cancer
- Resection of Tumor is planned with unilateral neck dissection
- Patient did not underwent any therapeutic treatment of the cancer before start of study
- Surgical therapy is planned with curative intent
Exclusion Criteria:
- Allergy to local anesthetics
- Coagulation disorders, which can lead to complications in regional anesthesia
- Insulin-dependent diabetes mellitus, polyneuropathy
- Severe psychiatric disorders
- Dementia
- Alcohol abuse, Korsakoff syndrome
- Medication with immunosuppressants or immune modulantia
- Patient under Special Care
- Refusal of study participation
- Pregnancy and breast feeding period.
- Participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion
- Lack of consent that pseudonomized data of the study may be saved and distributed
Sites / Locations
- Charité Universitaetsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SPRANC Block group
SPRANC Control group
Arm Description
General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.
General anaesthesia
Outcomes
Primary Outcome Measures
Expression of Substance P
Secondary Outcome Measures
Full Information
NCT ID
NCT03081897
First Posted
July 28, 2016
Last Updated
January 21, 2022
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT03081897
Brief Title
Regional Anaesthesia and Substance P in Head and Neck Cancer
Acronym
SPRANC
Official Title
Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
for organizational reasons
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance P in patients with unilateral Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side will be analysed by immunohistology, measuring the expression of the Substance P.
Detailed Description
Several investigations show that anesthetic procedures, and especially the perioperative regional anesthesia, can have a benefit for patients undergoing tumor surgery.The perioperative regional anesthesia might reduce the immunological response and therefore lower the risk of tumor relapse. Factors that might play a role in tumor relapse are various, so more prospective and randomised trials are necessary to investigate the underlying mechanisms.
In a retrospective analysis by Merquiol et al. it was shown that an cervical epidural anesthesia was associated with an extended tumorfree timeline of larynx and hypopharynx carcinoma.
Supporting results could be seen in a study by Munoz et al. performing regional anaesthesia in breast cancer patients.
Taking all these facts into consideration the investigators believe that performing regional aneasthesia could reduce the relapse of larynx carcinoma. The relapse of carcinoma is believed to be linked to substance P and the neurokinin 1 (NK-1) receptor .
It is accepted that an additional regional anesthesia could reduce the impact of substance P to gain a normal immune response in the perioperative setting and to reduce the rate of tumor relapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPRANC Block group
Arm Type
Experimental
Arm Description
General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.
Arm Title
SPRANC Control group
Arm Type
Active Comparator
Arm Description
General anaesthesia
Intervention Type
Drug
Intervention Name(s)
SPRANC Block group
Intervention Description
General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional anaesthesia (cervical plexus block) with an long acting local anesthetic according to clinical estimation of the treating anesthetist (about 15 ml Ropivacaine 0,75% around the carotid bifurcation, 5 ml Ropivacaine in the region of Erb´s Point of the superficial cervical plexus and 10 ml Ropivacaine at the area of skin incision on the tumor side); unilateral neck dissection.
Intervention Type
Drug
Intervention Name(s)
SPRANC Control group
Intervention Description
General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional Patient Control Group (no Intervention planned), general anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); unilateral neck dissection.
Primary Outcome Measure Information:
Title
Expression of Substance P
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at Charité - Universitaetsmedizin Berlin, Campus Charité Mitte
Primary diagnosis of unilateral head or neck cancer
Resection of Tumor is planned with unilateral neck dissection
Patient did not underwent any therapeutic treatment of the cancer before start of study
Surgical therapy is planned with curative intent
Exclusion Criteria:
Allergy to local anesthetics
Coagulation disorders, which can lead to complications in regional anesthesia
Insulin-dependent diabetes mellitus, polyneuropathy
Severe psychiatric disorders
Dementia
Alcohol abuse, Korsakoff syndrome
Medication with immunosuppressants or immune modulantia
Patient under Special Care
Refusal of study participation
Pregnancy and breast feeding period.
Participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion
Lack of consent that pseudonomized data of the study may be saved and distributed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Birnbaum, PD Dr
Organizational Affiliation
Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Regional Anaesthesia and Substance P in Head and Neck Cancer
We'll reach out to this number within 24 hrs