Shoulder Function After Level IIB Neck Dissection: A Randomized Controlled Study (2B/Not 2B)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Peter Dziegielewski, University of Alberta
ClinicalTrials.gov Identifier:
NCT00765791
First received: October 2, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Procedure: Selective Neck Dissection Including Level IIB
Procedure: Selective Neck Dissection Excluding Level IIB
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shoulder Function After Level IIB Neck Dissection: A Randomized Controlled

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. [ Time Frame: 6 months per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing [ Time Frame: 6 months per patients ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: December 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Level IIB is dissected
Procedure: Selective Neck Dissection Including Level IIB
Level IIB is dissected
Active Comparator: 2
Level IIB is not dissected
Procedure: Selective Neck Dissection Excluding Level IIB
Level IIB is not dissected

  Hide Detailed Description

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:

  1. occult disease may not respond to the RT
  2. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT).
  2. N0 neck disease on side of the dominant hand
  3. Willingness to participate in post-operative physiotherapy

Exclusion Criteria:

  1. IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa)
  2. Previous neck RT
  3. Previous chemotherapy
  4. Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance).
  5. Previous neck dissection
  6. Previous SAN injury or dysfunction
  7. Preoperative signs or formal diagnosis of myopathy or neuropathy
  8. Previous shoulder injury (muscular or bony)
  9. Level V neck dissection
  10. Recognized intraoperative sectioning of the SAN
  11. Unable to provide informed consent
  12. Cardiac pacemaker (contra-indication to EMG/Nerve conduction)
  13. Radial forearm free flap on dominant arm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765791

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Sponsors and Collaborators
Peter Dziegielewski
Investigators
Principal Investigator: Hadi R Seikaly, MD, FRCSC University of Alberta
  More Information

Publications:
Responsible Party: Peter Dziegielewski, Chief Resident, Otolaryngology-Head and Neck Surgery, University of Alberta
ClinicalTrials.gov Identifier: NCT00765791     History of Changes
Other Study ID Numbers: 7527
Study First Received: October 2, 2008
Last Updated: December 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
head and neck cancer
oral cancer
oropharyngeal cancer
laryngeal cancer
selective neck dissection
submuscular recess
level 2b

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on July 20, 2014