Head and Neck NeoplasmsTARGETNCT02647021
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors
A study testing Therapeutic Exercise and Therapeutic + Lower Body Exercise in people with Head and Neck Neoplasms and Accessory Nerve Injury, run by University of Alberta at 1 site in Canada.
Trial summary
The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Accessory Nerve Injury, Fatigue
- What is being tested?
- Therapeutic Exercise and Therapeutic + Lower Body Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2016to 30 Mar 2020
- Phase
- Interventional
- 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/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
- Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
- Presenting with shoulder and/ or neck dysfunction related to cancer treatment
- Karnofsky Performance Status greater than or equal to 60%
- No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
- Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
- Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.
Who cannot join
- A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
About this study
Official title: Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.
Read the detailed description
Participants will be stratified by early (within 18 months of surgery) and late (> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.
The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.
At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.
- Conditions
- Head and Neck Neoplasms, Accessory Nerve Injury, Fatigue
- Being tested
- Therapeutic Exercise, Therapeutic + Lower Body Exercise
- Keywords
- physical therapy, cancer rehabilitation, exercise
- Medical subject headings
- Head and Neck Neoplasms, Accessory Nerve Injuries, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseBehavioural
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
Therapeutic + Lower Body ExerciseBehavioural
A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise | Active comparator | Therapeutic Exercise Program (standard care) will include:
1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function. Receives: Behavioral: Therapeutic Exercise |
| Therapeutic + Lower Body Exercise | Experimental | The Therapeutic Exercise Program (standard care) will include:
1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.
The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks.
1. a personalized program of lower extremity resistance exercises
2. core strengthening exercises Receives: Behavioral: Therapeutic Exercise; Behavioral: Therapeutic + Lower Body Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Cancer related fatigue
Measured: change from baseline to 12 weeks.
Secondary outcomes (13)
Shoulder range of motion in degrees.
Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.
Measured: Change from baseline to one year
Body mass index
Derived from height and weight of the participant.
Measured: Change from baseline to 24 weeks.
1 repetition maximum (1RM) strength for seated row in pounds.
The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form.
Measured: Change from baseline to 12 weeks.
Neck Range of Motion in degrees.
Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.
Measured: Change from baseline to 12 weeks.
Upper extremity muscular endurance: number of repetitions performed.
Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.
Measured: baseline, 12-weeks, 24-weeks, one year
Lower extremity flexibility in centimetres.
Sit and reach test
Measured: Change from baseline to 12-weeks.
Functional capacity
6 minute walk test
Measured: Change from baseline to 24 weeks.
Neck Dissection Impairment Index
Neck dissection related quality of life
Measured: Change from baseline to one year.
Grip strength in pounds.
Maximal grip strength: composite score of both hands. Best of three attempts for each side.
Measured: Change from baseline to 12-weeks.
1 repetition maximum leg press in pounds
The maximal amount of weight that can be moved with proper
Measured: Change from baseline to 12 weeks.
1 repetition maximum chest press in pounds.
The maximal amount of weight that can be pushed with proper form.
Measured: Change from baseline to 12 weeks.
30 second sit to stand (optional: in lieu of leg press)
number of repetitions performed in 30 seconds
Measured: Change from baseline to 12 weeks.
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
The composite score of physical, functional and fatigue subscales of the questionnaire.
Measured: Baseline to 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start31 Mar 2016
- Primary completion15 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Principal investigator, Margie McNeely, University of Alberta
- Investigators
- Margaret L. McNeely, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647021
- Sponsor's protocol ID
- HREBA.CC.15-0167
- Acronym
- TARGET
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2015
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02647021
- Acronym / sponsor ID
- TARGET / HREBA.CC.15-0167
- Conditions
- Head and Neck Neoplasms, Accessory Nerve Injury, Fatigue
- Keywords
- physical therapy, cancer rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 6 Jan 2016 (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 investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.
Detailed description
Participants will be stratified by early (within 18 months of surgery) and late (> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.
The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.
At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise | Active comparator | Behavioral: Therapeutic ExerciseTherapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function. |
| Therapeutic + Lower Body Exercise | Experimental | Behavioral: Therapeutic Exercise, Behavioral: Therapeutic + Lower Body ExerciseThe Therapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function. The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks. 1. a personalized program of lower extremity resistance exercises 2. core strengthening exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
- Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
- Presenting with shoulder and/ or neck dysfunction related to cancer treatment
- Karnofsky Performance Status greater than or equal to 60%
- No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
Key exclusion criteria (1 listed)
- A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.
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 |
|---|---|---|
| Therapeutic ExerciseA specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage. | Behavioural | Therapeutic + Lower Body Exercise, Therapeutic Exercise |
| Therapeutic + Lower Body ExerciseA combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise | Behavioural | Therapeutic + Lower Body Exercise |
Primary outcome
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Time frame: change from baseline to 12 weeks.
Cancer related fatigue
13 secondary outcomes
Shoulder range of motion in degrees.
Time frame: Change from baseline to one year
Body mass index
Time frame: Change from baseline to 24 weeks.
1 repetition maximum (1RM) strength for seated row in pounds.
Time frame: Change from baseline to 12 weeks.
Neck Range of Motion in degrees.
Time frame: Change from baseline to 12 weeks.
Upper extremity muscular endurance: number of repetitions performed.
Time frame: baseline, 12-weeks, 24-weeks, one year
Lower extremity flexibility in centimetres.
Time frame: Change from baseline to 12-weeks.
Functional capacity
Time frame: Change from baseline to 24 weeks.
Neck Dissection Impairment Index
Time frame: Change from baseline to one year.
Grip strength in pounds.
Time frame: Change from baseline to 12-weeks.
1 repetition maximum leg press in pounds
Time frame: Change from baseline to 12 weeks.
1 repetition maximum chest press in pounds.
Time frame: Change from baseline to 12 weeks.
30 second sit to stand (optional: in lieu of leg press)
Time frame: Change from baseline to 12 weeks.
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
Time frame: Baseline to 12-weeks.
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 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Margaret L. McNeely, PhD principal investigator
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 study testing Therapeutic Exercise and Therapeutic + Lower Body Exercise in people with Head and Neck Neoplasms and Accessory Nerve Injury, 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 7 inclusion and 1 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 3 Jan 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.
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?
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire (time frame: change from baseline to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.