This trial is active, not recruiting.

Condition head and neck neoplasms
Treatment exercise
Phase phase 2/phase 3
Sponsor University of Alberta, Physical Education
Start date September 2005
End date September 2005
Trial size 64 participants
Trial identifier NCT00248235, HN-4-0023


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
time frame:
Active and passive range of motion (baseline, 12 weeks)
time frame:
Muscular strength and endurance (baseline, 12 weeks)
time frame:
Quality of life (baseline, 12 weeks, 6 months, 12 months)
time frame:

Secondary Outcomes

Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
time frame:
Nerve conduction testing (baseline, 12 weeks as indicated)
time frame:
Electromyography (baseline, 12 weeks as indicated)
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
Principal investigator Kerry S Courneya, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by University of Alberta, Physical Education.