Regional Anaesthesia and Substance P in Head and Neck Cancer

Not Applicable

Suspended

• Conditions: Head and Neck Cancer
• Interventions: Drug: SPRANC Control group; Drug: SPRANC Block group

• Registration Number: NCT03081897
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPRANC Control group	SPRANC Control group	General anaesthesia
SPRANC Block group	SPRANC Block group	General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.

Primary Outcome Measures

Name	Time	Method
Expression of Substance P	2 years

Trial Locations

Locations (1)

Charité Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany