Head and Neck Neoplasms
Conditions
Keywords
exercise, rehabilitation, head and neck neoplasms
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.
Interventions
BEHAVIORALExercise
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months) | baseline, 12 weeks, 6 months, 12 months |
| Active and passive range of motion (baseline, 12 weeks) | baseline, 12 weeks |
| Muscular strength and endurance (baseline, 12 weeks) | baseline, 12 weeks |
| Quality of life (baseline, 12 weeks, 6 months, 12 months) | baseline, 12 weeks, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Nerve conduction testing (baseline, 12 weeks as indicated) | Baseline |
| Electromyography (baseline, 12 weeks as indicated) | Baseline |
| Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months) | baseline, 12 weeks, 6 months, 12 months |
Countries
Canada
Outcome results
None listed