Clinical trial NCT03081897: Regional Anaesthesia and Substance P in Head and Neck Cancer
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
Overall status: SUSPENDED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Expression of Substance P
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
Study officials:
affiliation: Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte
name: Juergen Birnbaum, PD Dr
role: PRINCIPAL_INVESTIGATOR
References: