Head and Neck CancerSPRANCNCT03081897
Regional Anaesthesia and Substance P in Head and Neck Cancer
A study testing SPRANC Block group in people with Head and Neck Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- SPRANC Block group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to 1 Jul 2023
- 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 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- SPRANC Block group, SPRANC Control group
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRANC Block groupDrug
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.
SPRANC Control groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SPRANC Block group | Experimental | General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side. Receives: Drug: SPRANC Block group |
| SPRANC Control group | Active comparator | General anaesthesia Receives: Drug: SPRANC Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Substance P
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study startJul 2016
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: for organizational reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Birnbaum, Charite University, Berlin, Germany
- Investigators
- Juergen Birnbaum, PD Dr, Principal investigator, Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081897
- Sponsor's protocol ID
- EA1/119/16
- Acronym
- SPRANC
- Status last verified
- Jan 2022
- First submitted
- 28 Jul 2016
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03081897
- Acronym / sponsor ID
- SPRANC / EA1/119/16
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: for organizational reasons
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 16 Mar 2017 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPRANC Block group | Experimental | Drug: SPRANC Block groupGeneral anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side. |
| SPRANC Control group | Active comparator | Drug: SPRANC Control groupGeneral anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Allergy to local anesthetics
- Coagulation disorders, which can lead to complications in regional anesthesia
- Insulin-dependent diabetes mellitus, polyneuropathy
- Severe psychiatric disorders
- Dementia
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 |
|---|---|---|
| SPRANC Block groupGeneral 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. | Drug | SPRANC Block group |
| SPRANC Control groupGeneral 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. | Drug | SPRANC Control group |
Primary outcome
Expression of Substance P
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Juergen Birnbaum, PD Dr principal investigator
Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPRANC Block group in people with Head and Neck Cancer, run by Charite University, Berlin, Germany 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 5 inclusion and 12 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: paused, as of the sponsor's last update on 4 Feb 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of Substance P (time frame: 2 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 4 Feb 2022.