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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765791
Recruitment Status : Unknown
Verified December 2013 by Peter Dziegielewski, University of Alberta.
Recruitment status was:  Enrolling by invitation
First Posted : October 3, 2008
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Peter Dziegielewski, University of Alberta

Brief 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. 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 or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Procedure: Selective Neck Dissection Including Level IIB Procedure: Selective Neck Dissection Excluding Level IIB Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shoulder Function After Level IIB Neck Dissection: A Randomized Controlled
Study Start Date : December 2008
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. [ Time Frame: 6 months per patient ]

Secondary Outcome Measures :
  1. Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing [ Time Frame: 6 months per patients ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765791

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

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Responsible Party: Peter Dziegielewski, Chief Resident, Otolaryngology-Head and Neck Surgery, University of Alberta Identifier: NCT00765791     History of Changes
Other Study ID Numbers: 7527
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Keywords provided by Peter Dziegielewski, University of Alberta:
head and neck cancer
oral cancer
oropharyngeal cancer
laryngeal cancer
selective neck dissection
submuscular recess
level 2b
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site