Clinical trial NCT00248235: Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer
Official title: Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Head and Neck Neoplasms
Keywords: exercise
rehabilitation
head and neck neoplasms
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2005-11-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
timeFrame: baseline, 12 weeks, 6 months, 12 months
measure: Active and passive range of motion (baseline, 12 weeks)
timeFrame: baseline, 12 weeks
measure: Muscular strength and endurance (baseline, 12 weeks)
timeFrame: baseline, 12 weeks
measure: Quality of life (baseline, 12 weeks, 6 months, 12 months)
timeFrame: baseline, 12 weeks, 6 months, 12 months
Secondary outcomes:
measure: Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
timeFrame: baseline, 12 weeks, 6 months, 12 months
measure: Nerve conduction testing (baseline, 12 weeks as indicated)
timeFrame: Baseline
measure: Electromyography (baseline, 12 weeks as indicated)
timeFrame: Baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Behavioral Medicine Laboratory, University of Alberta
state: Alberta
Study officials:
affiliation: Professor, Faculty of Physical Education and Recreation, University of Alberta
name: Kerry S Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/hed.20010.