Regional Anaesthesia and Substance P in Head and Neck Cancer | NCT03081897

Studies
Regional Anaesthesia and Substance P in Head and Neck Cancer

NCT03081897

Sponsor

Charite University, Berlin, Germany

Status

Suspended

Last Update Posted

Feb 4, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

SPRANC Block group
SPRANC Control group

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

for organizational reasons

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Jul 28, 2016

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2022

Last Update Posted Date

Feb 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jurgen Birnbaum, Principal Investigator of the Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPRANC Block group	Experimental	General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.	Drug: SPRANC Block group
SPRANC Control group	Active Comparator	General anaesthesia	Drug: SPRANC Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPRANC Block group	Drug	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.

Measure	Description	Time Frame
Expression of Substance P		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juergen Birnbaum, PD Dr	Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitaetsmedizin Berlin		Berlin		10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms