2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled Study

NCT00765791 | Completed DMC

• 1 other identifier: 7527
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.

  6 months per patient

Secondary Outcomes (1)

• Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing

  6 months per patients

Study Arms (2)

Group 1 (Not 2B)

ACTIVE COMPARATOR

Selective neck dissection is performed on the dominant arm. Level 2B is not dissected.

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.

Procedure: Selective Neck Dissection Including Level 2B

Interventions

Selective Neck Dissection Excluding Level 2B PROCEDURE

Selective neck dissection is performed. Level 2a is dissected; level 2b is not dissected.

Also known as: Not 2B

Group 1 (Not 2B)

Selective Neck Dissection Including Level 2B PROCEDURE

Selective neck dissection is performed. Level 2a is dissected; level 2b is also dissected.

Also known as: 2B

Group 2 (2B)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Related Publications (7)

• 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.

  PMID: 11226954 BACKGROUND

• Cappiello 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.

  PMID: 15689746 BACKGROUND

• Smith 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.

  PMID: 17942033 BACKGROUND

• Silverman 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.

  PMID: 12874072 BACKGROUND

• Paleri 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.

  PMID: 17712854 BACKGROUND

• Talmi 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.

  PMID: 9790288 BACKGROUND

• Dziegielewski 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.

  PMID: 31873950 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Hadi R Seikaly, MD, FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2017
• Last Updated: June 9, 2022

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)