Head and Neck NeoplasmsPhase 2/3NCT00248235
Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer
A Phase 2/3 study testing Exercise in people with Head and Neck Neoplasms, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jan 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
- Karnofsky Performance Status greater than or equal to 60%
- No evidence of residual cancer in the neck and no distant (M0) metastasis
- Participants must have completed their head and neck cancer treatment
Who cannot join
- A history of shoulder or neck pathology unrelated to cancer treatment
- Serious co-morbid medical illness or psychiatric illness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioral Medicine Laboratory, University of Alberta
Edmonton, Alberta, T6G 2H9
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Exercise
- Keywords
- exercise, rehabilitation, head and neck neoplasms
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PRET | Experimental | Progressive Resistance Exercise Training: upper extremity 6-8 exercises Receives: Behavioral: Exercise |
| Standard Care | Active comparator | Standard Care: physical therapy - range of motion, 6-8 strengthening exercises Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Measured: baseline, 12 weeks, 6 months, 12 months
Active and passive range of motion (baseline, 12 weeks)
Measured: baseline, 12 weeks
Muscular strength and endurance (baseline, 12 weeks)
Measured: baseline, 12 weeks
Quality of life (baseline, 12 weeks, 6 months, 12 months)
Measured: baseline, 12 weeks, 6 months, 12 months
Secondary outcomes (3)
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
Measured: baseline, 12 weeks, 6 months, 12 months
Nerve conduction testing (baseline, 12 weeks as indicated)
Measured: Baseline
Electromyography (baseline, 12 weeks as indicated)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry S Courneya, PhD, Principal investigator, Professor, Faculty of Physical Education and Recreation, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248235
- Sponsor's protocol ID
- HN-4-0023
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2005
- Last updated
- 5 Nov 2024
- Results posted
- No
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.
PubMed 15162353
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT00248235
- Acronym / sponsor ID
- HN-4-0023
- Conditions
- Head and Neck Neoplasms
- Keywords
- exercise, rehabilitation, head and neck neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRET | Experimental | Behavioral: ExerciseProgressive Resistance Exercise Training: upper extremity 6-8 exercises |
| Standard Care | Active comparator | Behavioral: ExerciseStandard Care: physical therapy - range of motion, 6-8 strengthening exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
- Karnofsky Performance Status greater than or equal to 60%
- No evidence of residual cancer in the neck and no distant (M0) metastasis
- Participants must have completed their head and neck cancer treatment
Key exclusion criteria (2 listed)
- A history of shoulder or neck pathology unrelated to cancer treatment
- Serious co-morbid medical illness or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Behavioural | PRET, Standard Care |
Primary outcome
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
Active and passive range of motion (baseline, 12 weeks)
Time frame: baseline, 12 weeks
Muscular strength and endurance (baseline, 12 weeks)
Time frame: baseline, 12 weeks
Quality of life (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
3 secondary outcomes
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
Nerve conduction testing (baseline, 12 weeks as indicated)
Time frame: Baseline
Electromyography (baseline, 12 weeks as indicated)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 15162353McNeely 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Courneya, PhD principal investigator
Professor, Faculty of Physical Education and Recreation, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exercise in people with Head and Neck Neoplasms, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months) (time frame: baseline, 12 weeks, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.