Status:
COMPLETED
2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled Study
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Alberta Health services
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
NA
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...
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 neces...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00765791
Start Date
December 1 2008
End Date
June 1 2017
Last Update
June 9 2022
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7