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Sponsored by: |
University of Alberta |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00765791 |
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 |
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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: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Shoulder Function After Level IIB Neck Dissection: A Randomized Controlled |
Estimated Enrollment: | 32 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Level IIB is dissected
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Procedure: Selective Neck Dissection Including Level IIB
Level IIB is dissected
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2: Active Comparator
Level IIB is not dissected
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Procedure: Selective Neck Dissection Excluding Level IIB
Level IIB is not dissected
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter T Dziegielewski, MD | 780-407-8822 | ptd@ualberta.ca |
Contact: Hadi R Seikaly, MD, FRCSC | 780-407-8822 | hseikaly@shaw.ca |
Canada, Alberta | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada, T6G2B7 |
Principal Investigator: | Hadi R Seikaly, MD, FRCSC | University of Alberta |
Responsible Party: | University of Alberta ( Dr. H. Seikaly - Director of the Division of Otolaryngology - Head and Neck Surgery ) |
Study ID Numbers: | 7527 |
Study First Received: | October 2, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00765791 |
Health Authority: | Canada: Ethics Review Committee |
head and neck cancer oral cancer oropharyngeal cancer laryngeal cancer |
selective neck dissection submuscular recess level 2b |
Squamous cell carcinoma Laryngeal Neoplasms Mouth Neoplasms Lip and oral cavity cancer Carcinoma Epidermoid carcinoma Head and Neck Neoplasms |
Oral cancer Carcinoma, squamous cell Laryngeal carcinoma Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type |