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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2H9
      • Behavioral Medicine Laboratory, University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRET; Progressive Resistance Exercise Training: upper extremity 6-8 exercises	Behavioral: Exercise
Active Comparator: Standard Care; Standard Care: physical therapy - range of motion, 6-8 strengthening exercises	Behavioral: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)	baseline, 12 weeks, 6 months, 12 months
Nerve conduction testing (baseline, 12 weeks as indicated)	Baseline
Electromyography (baseline, 12 weeks as indicated)	Baseline

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Kerry S Courneya, PhD, Professor, Faculty of Physical Education and Recreation, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: November 1, 2005
• First Submitted That Met QC Criteria: November 1, 2005
• First Posted (Estimated): November 3, 2005

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; head and neck neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: HN-4-0023