Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:

Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00248235
• Other study ID #: HN-4-0023
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 1, 2005
• Last updated: January 31, 2007
• Start date: September 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: University of Alberta, Physical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.

Description:

We will be conducting a randomized controlled trial to evaluate the effects of progressive resistance exercise training (PRET) on shoulder and neck dysfunction due to spinal accessory neurapraxia/ neurectomy in patients with head and neck cancer. Sixty-four head and neck cancer survivors will be randomly assigned to PRET or standard care. Participants assigned to the PRET group will exercise 3 times per week for 12 weeks. The goal of the exercise program will be to enhance scapular stability, and improve mobility and strength of the upper extremity. The resistance exercise program will be progressive in terms of the number of sets and repetitions performed, as well as amount lifted, depending on baseline strength levels and overall performance status. The primary outcomes for the study include pain and dysfunction, active and passive range of motion measures, strength and endurance testing, and quality of life. Nerve conduction testing and electromyography will be performed to assess/ monitor the status of the spinal accessory nerve and trapezius muscle function respectively.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck

2. Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection

3. Karnofsky Performance Status greater than or equal to 60%

4. No evidence of residual cancer in the neck and no distant (M0) metastasis

5. Participants must have completed their head and neck cancer treatment

Exclusion Criteria:

1. A history of shoulder or neck pathology unrelated to cancer treatment

2. Serious co-morbid medical illness or psychiatric illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
Canada	Behavioral Medicine Laboratory, University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta, Physical Education

Country where clinical trial is conducted

Canada, 

References & Publications (1)

McNeely ML, Parliament M, Courneya KS, Seikaly H, Jha N, Scrimger R, Hanson J. A pilot study of a randomized controlled trial to evaluate the effects of progressive resistance exercise training on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in head and neck cancer survivors. Head Neck. 2004 Jun;26(6):518-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Primary	Active and passive range of motion (baseline, 12 weeks)
Primary	Muscular strength and endurance (baseline, 12 weeks)
Primary	Quality of life (baseline, 12 weeks, 6 months, 12 months)
Secondary	Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
Secondary	Nerve conduction testing (baseline, 12 weeks as indicated)
Secondary	Electromyography (baseline, 12 weeks as indicated)