Head and Neck Squamous Cell Carcinoma2BN2BNCT00765791
2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled Study
A study testing Selective Neck Dissection Excluding Level 2B and Selective Neck Dissection Including Level 2B in people with Head and Neck Squamous Cell Carcinoma, run by University of Alberta at 1 site in Canada.
Trial summary
Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Selective Neck Dissection Excluding Level 2B and Selective Neck Dissection Including Level 2B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Jun 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT).
- N0 neck disease on side of the dominant hand
- Willingness to participate in post-operative physiotherapy
Who cannot join
- IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa)
- Previous neck RT
- Previous chemotherapy
- Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance).
- Previous neck dissection
- Previous SAN injury or dysfunction
Show all 13Show fewer
- Preoperative signs or formal diagnosis of myopathy or neuropathy
- Previous shoulder injury (muscular or bony)
- Level V neck dissection
- Recognized intraoperative sectioning of the SAN
- Unable to provide informed consent
- Cardiac pacemaker (contra-indication to EMG/Nerve conduction)
- Radial forearm free flap on dominant arm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled
Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Level IIB has been particularly controversial in the last few years, as the rate of cancer spread to this area has been shown to be quite low (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs through this area, there is theoretical risk of causing post-operative shoulder weakness. As such, the question of whether removing level IIB, knowing that there is low chance of it containing disease spread, is worth risking decreased shoulder function. Some would argue that all potential diseased sites should be removed at all costs. While other advocate that a balance between disease cure and function should be maintained. However, what needs to be determined is just what impact does dissecting IIB have on shoulder function. At our institution, the rate of poor shoulder function associated with selective neck dissection has been perceived as being quite low. This study is designed to test this observation.
Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not lead to worse shoulder function and quality of life than when level IIb is preserved.
Read the detailed description
The lymphatic fluid of upper aerodigestive tract (UADT) drains into various levels of the neck. When cancer occurs in the UADT, the potential for local metastatic spread to the neck exists, thus necessitating treatment of the neck. Ideally all potential neck structures, which could harbor cancer cells or provide a dock for recurrence, would be eradicated. Unfortunately, such radical treatments have shown to cause extreme rates of morbidity with little extra oncologic benefit. Thus, head and neck oncologists have strived to create treatment paradigms, which maximize cure rates while minimizing morbidity. Finding this intricate balance has translated to selective neck dissection (SND) and post-operative RT.1
Increased understanding of lymphatic drainage patterns in the head and neck has lead to widespread use of SND. Through removal of lymphatics in neck levels with the highest risk of harboring cancer cells, based on primary tumor site, important neck structures may be preserved. As such, the treatment remains oncologically sound and avoids the morbidity associated with its predecessor, the radical neck dissection. 1
One of the structures preserved in the SND is the spinal accessory nerve (SAN), which is responsible for providing motor innervation to the sternocleidomastoid (SCM) and trapezius muscles. Thus, it is intricately involved in shoulder function. The nerve exists the skull base at the jugular foramen and obliquely passes through neck level II. It then passes posterior to the SCM and eventually enters the trapezius muscles. Through this trajectory, it divides level II into IIa (anterior to the SAN) and IIb (posterior to the SAN).
It is known that shoulder function significantly deteriorates when level V is dissected.2 This is likely due to traction and devascularization injury of the longest portion of the SAN in the neck. As such, practice has become such that level V is left intact in cases where it does not harbor detectable disease or when occult disease incidence is very low. Due to the intimate relationship of IIb with the SAN, there is also potential for injury to the nerve in this area.2 As such, debate has arisen to the necessity of including IIb in the neck dissection specimen. Studies have shown that the prevalence of occult nodal disease in IIb ranges from 0-8.7.5% depending on the overall n stage of the neck.3-5 These figures have lead head and neck surgeons to weigh the benefits of not excising lymphatic tissue with low nodal metastatic rates versus excising the area and decreasing post-operative shoulder function.6
Because the incidence of occult metastases in IIb is low3-5, it has become standard of care in many centers to spare IIb, if it is oncologically feasible, in SND to preserve shoulder function. Because these patients receive post-operative RT it is thought that the RT will address any occult disease. Unfortunately, relying on RT poses two problems:
- occult disease may not respond to the RT
- leaving level IIb intact provides a lymphatic route of recurrence despite undergoing RT By surgically removing all portals of lymphatic disease spread these issues above can be eliminated.
The goal of this study is to demonstrate that the minimal manipulation of the SAN associated with IIb dissection will not have a significant impact on post-operative shoulder function. If this is the case, the standard of practice should be changed to include IIb in the SND specimen in cases where level IIa is dissected as well. This would eliminate any further lymphatic tissue, which may harbor disease.
Note: At the University of Alberta, some head and neck surgeons prefer to spare IIb in SND, while others prefer to resect it. Thus, the protocol in this study does not manipulate current standards of practice.
*Reference numbers correspond to articles in the "Citations" section. The citations are in order of appearance in the above text.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Selective Neck Dissection Excluding Level 2B, Selective Neck Dissection Including Level 2B
- Keywords
- head and neck cancer, oral cancer, oropharyngeal cancer, laryngeal cancer, selective neck dissection, submuscular recess, level 2b
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Neck Dissection Excluding Level 2BProcedure or surgery
Also called Not 2B
Selective neck dissection is performed. Level 2a is dissected; level 2b is not dissected.
Selective Neck Dissection Including Level 2BProcedure or surgery
Also called 2B
Selective neck dissection is performed. Level 2a is dissected; level 2b is also dissected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Not 2B) | Active comparator | Selective neck dissection is performed on the dominant arm. Level 2B is not dissected. Receives: Procedure: Selective Neck Dissection Excluding Level 2B |
| Group 2 (2B) | Active comparator | Selective neck dissection is performed on the dominant arm. Level 2B is dissected. Receives: Procedure: Selective Neck Dissection Including Level 2B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.
Measured: 6 months per patient
Secondary outcomes (1)
Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing
Measured: 6 months per patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Hadi R Seikaly, MD, FRCSC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765791
- Sponsor's protocol ID
- 7527
- Acronym
- 2BN2B
- Status last verified
- Aug 2019
- First submitted
- 2 Oct 2008
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make data available to others.
Publications
Ambrosch P, Kron M, Pradier O, Steiner W. Efficacy of selective neck dissection: a review of 503 cases of elective and therapeutic treatment of the neck in squamous cell carcinoma of the upper aerodigestive tract. Otolaryngol Head Neck Surg. 2001 Feb;124(2):180-7. doi: 10.1067/mhn.2001.111598.
PubMed 11226954Cappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. doi: 10.1097/01.mlg.0000154729.31281.da.
PubMed 15689746Smith R, Taylor SM, Trites JR, Smith A. Patterns of lymph node metastases to the submuscular recess. J Otolaryngol. 2007 Aug;36(4):203-7. doi: 10.2310/7070.2007.0033.
PubMed 17942033Silverman DA, El-Hajj M, Strome S, Esclamado RM. Prevalence of nodal metastases in the submuscular recess (level IIb) during selective neck dissection. Arch Otolaryngol Head Neck Surg. 2003 Jul;129(7):724-8. doi: 10.1001/archotol.129.7.724.
PubMed 12874072Paleri V, Kumar Subramaniam S, Oozeer N, Rees G, Krishnan S. Dissection of the submuscular recess (sublevel IIb) in squamous cell cancer of the upper aerodigestive tract: prospective study and systematic review of the literature. Head Neck. 2008 Feb;30(2):194-200. doi: 10.1002/hed.20682.
PubMed 17712854Talmi YP, Hoffman HT, Horowitz Z, McCulloch TM, Funk GF, Graham SM, Peleg M, Yahalom R, Teicher S, Kronenberg J. Patterns of metastases to the upper jugular lymph nodes (the "submuscular recess"). Head Neck. 1998 Dec;20(8):682-6. doi: 10.1002/(sici)1097-0347(199812)20:83.0.co;2-j.
PubMed 9790288Dziegielewski PT, McNeely ML, Ashworth N, O'Connell DA, Barber B, Courneya KS, Debenham BJ, Seikaly H. 2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial. Cancer. 2020 Apr 1;126(7):1492-1501. doi: 10.1002/cncr.32681. Epub 2019 Dec 24.
PubMed 31873950
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT00765791
- Acronym / sponsor ID
- 2BN2B / 7527
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck cancer, oral cancer, oropharyngeal cancer, laryngeal cancer, selective neck dissection, submuscular recess, level 2b
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Oct 2008 (estimated)
- 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.
Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Level IIB has been particularly controversial in the last few years, as the rate of cancer spread to this area has been shown to be quite low (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs through this area, there is theoretical risk of causing post-operative shoulder weakness. As such, the question of whether removing level IIB, knowing that there is low chance of it containing disease spread, is worth risking decreased shoulder function. Some would argue that all potential diseased sites should be removed at all costs. While other advocate that a balance between disease cure and function should be maintained. However, what needs to be determined is just what impact does dissecting IIB have on shoulder function. At our institution, the rate of poor shoulder function associated with selective neck dissection has been perceived as being quite low. This study is designed to test this observation.
Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not lead to worse shoulder function and quality of life than when level IIb is preserved.
Detailed description
The lymphatic fluid of upper aerodigestive tract (UADT) drains into various levels of the neck. When cancer occurs in the UADT, the potential for local metastatic spread to the neck exists, thus necessitating treatment of the neck. Ideally all potential neck structures, which could harbor cancer cells or provide a dock for recurrence, would be eradicated. Unfortunately, such radical treatments have shown to cause extreme rates of morbidity with little extra oncologic benefit. Thus, head and neck oncologists have strived to create treatment paradigms, which maximize cure rates while minimizing morbidity. Finding this intricate balance has translated to selective neck dissection (SND) and post-operative RT.1
Increased understanding of lymphatic drainage patterns in the head and neck has lead to widespread use of SND. Through removal of lymphatics in neck levels with the highest risk of harboring cancer cells, based on primary tumor site, important neck structures may be preserved. As such, the treatment remains oncologically sound and avoids the morbidity associated with its predecessor, the radical neck dissection. 1
One of the structures preserved in the SND is the spinal accessory nerve (SAN), which is responsible for providing motor innervation to the sternocleidomastoid (SCM) and trapezius muscles. Thus, it is intricately involved in shoulder function. The nerve exists the skull base at the jugular foramen and obliquely passes through neck level II. It then passes posterior to the SCM and eventually enters the trapezius muscles. Through this trajectory, it divides level II into IIa (anterior to the SAN) and IIb (posterior to the SAN).
It is known that shoulder function significantly deteriorates when level V is dissected.2 This is likely due to traction and devascularization injury of the longest portion of the SAN in the neck. As such, practice has become such that level V is left intact in cases where it does not harbor detectable disease or when occult disease incidence is very low. Due to the intimate relationship of IIb with the SAN, there is also potential for injury to the nerve in this area.2 As such, debate has arisen to the necessity of including IIb in the neck dissection specimen. Studies have shown that the prevalence of occult nodal disease in IIb ranges from 0-8.7.5% depending on the overall n stage of the neck.3-5 These figures have lead head and neck surgeons to weigh the benefits of not excising lymphatic tissue with low nodal metastatic rates versus excising the area and decreasing post-operative shoulder function.6
Because the incidence of occult metastases in IIb is low3-5, it has become standard of care in many centers to spare IIb, if it is oncologically feasible, in SND to preserve shoulder function. Because these patients receive post-operative RT it is thought that the RT will address any occult disease. Unfortunately, relying on RT poses two problems:
- occult disease may not respond to the RT
- leaving level IIb intact provides a lymphatic route of recurrence despite undergoing RT By surgically removing all portals of lymphatic disease spread these issues above can be eliminated.
The goal of this study is to demonstrate that the minimal manipulation of the SAN associated with IIb dissection will not have a significant impact on post-operative shoulder function. If this is the case, the standard of practice should be changed to include IIb in the SND specimen in cases where level IIa is dissected as well. This would eliminate any further lymphatic tissue, which may harbor disease.
Note: At the University of Alberta, some head and neck surgeons prefer to spare IIb in SND, while others prefer to resect it. Thus, the protocol in this study does not manipulate current standards of practice.
*Reference numbers correspond to articles in the "Citations" section. The citations are in order of appearance in the above text.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Not 2B) | Active comparator | Procedure: Selective Neck Dissection Excluding Level 2BSelective neck dissection is performed on the dominant arm. Level 2B is not dissected. |
| Group 2 (2B) | Active comparator | Procedure: Selective Neck Dissection Including Level 2BSelective neck dissection is performed on the dominant arm. Level 2B is dissected. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT).
- N0 neck disease on side of the dominant hand
- Willingness to participate in post-operative physiotherapy
Key exclusion criteria (13 listed)
- IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa)
- Previous neck RT
- Previous chemotherapy
- Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance).
- Previous neck dissection
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 |
|---|---|---|
| Selective Neck Dissection Excluding Level 2BAlso: Not 2BSelective neck dissection is performed. Level 2a is dissected; level 2b is not dissected. | Procedure or surgery | Group 1 (Not 2B) |
| Selective Neck Dissection Including Level 2BAlso: 2BSelective neck dissection is performed. Level 2a is dissected; level 2b is also dissected. | Procedure or surgery | Group 2 (2B) |
Primary outcome
Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.
Time frame: 6 months per patient
1 secondary outcome
Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing
Time frame: 6 months per patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 11226954Ambrosch P, Kron M, Pradier O, Steiner W. Efficacy of selective neck dissection: a review of 503 cases of elective and therapeutic treatment of the neck in squamous cell carcinoma of the upper aerodigestive tract. Otolaryngol Head Neck Surg. 2001 Feb;124(2):180-7. doi: 10.1067/mhn.2001.111598.
- Background: PubMed 15689746Cappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. doi: 10.1097/01.mlg.0000154729.31281.da.
- Background: PubMed 17942033Smith R, Taylor SM, Trites JR, Smith A. Patterns of lymph node metastases to the submuscular recess. J Otolaryngol. 2007 Aug;36(4):203-7. doi: 10.2310/7070.2007.0033.
- Background: PubMed 12874072Silverman DA, El-Hajj M, Strome S, Esclamado RM. Prevalence of nodal metastases in the submuscular recess (level IIb) during selective neck dissection. Arch Otolaryngol Head Neck Surg. 2003 Jul;129(7):724-8. doi: 10.1001/archotol.129.7.724.
- Background: PubMed 17712854Paleri V, Kumar Subramaniam S, Oozeer N, Rees G, Krishnan S. Dissection of the submuscular recess (sublevel IIb) in squamous cell cancer of the upper aerodigestive tract: prospective study and systematic review of the literature. Head Neck. 2008 Feb;30(2):194-200. doi: 10.1002/hed.20682.
- Background: PubMed 9790288Talmi YP, Hoffman HT, Horowitz Z, McCulloch TM, Funk GF, Graham SM, Peleg M, Yahalom R, Teicher S, Kronenberg J. Patterns of metastases to the upper jugular lymph nodes (the "submuscular recess"). Head Neck. 1998 Dec;20(8):682-6. doi: 10.1002/(sici)1097-0347(199812)20:83.0.co;2-j.
- Derived from this study: PubMed 31873950Dziegielewski PT, McNeely ML, Ashworth N, O'Connell DA, Barber B, Courneya KS, Debenham BJ, Seikaly H. 2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial. Cancer. 2020 Apr 1;126(7):1492-1501. doi: 10.1002/cncr.32681. Epub 2019 Dec 24.
- Individual participant dataSharing planned: No. There is no plan to make data available to others.
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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.
Hadi R Seikaly, MD, FRCSC principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Neck Dissection Excluding Level 2B and Selective Neck Dissection Including Level 2B in people with Head and Neck Squamous Cell Carcinoma, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 9 Jun 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. (time frame: 6 months per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765791, which also lists 7 linked publications.
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 9 Jun 2022.