Head and Neck NeoplasmsNCT04013178
Exercise After Radiation for Head & Neck Cancer
A study testing Accentuated eccentric loading + electromyostimulation and Conventional resistance training in people with Head and Neck Neoplasms, run by University of Calgary at 1 site in Canada.
Trial summary
People who receive radiation therapy for head and neck cancer (HNC) can experience side-effects which include a significant loss in body mass and a loss of muscle mass (cancer cachexia). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Accentuated eccentric loading + electromyostimulation and Conventional resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2017to 26 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a verified clinical diagnosis of head and neck cancer (stage I-IV) with the primary tumor in the oral cavity, pharynx, larynx, paranasal sinuses, or salivary glands.
- received radiation therapy ± concomitant chemotherapy
- able to walk without assistance
- received Canadian Society for Exercise Physiology-Certified Exercise Physiologist (CSEP-CEP) approval via The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and/or physician approval
- willing/able to travel to the University of Calgary (Calgary, AB).
Who cannot join
- comorbidities that could confound the ability to participate in laboratory tests (e.g. other malignancies, neuromuscular, musculoskeletal or vascular conditions affecting the lower extremities, such as radiculopathy or myopathy, (where the research team were consulted for individual cases)
- presence of a percutaneous endoscopic gastrostomy
- unable to follow verbal instructions in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer
People who receive radiation therapy for head and neck cancer (HNC) can experience side-effects which include a significant loss in body mass and a loss of muscle mass (cancer cachexia). Some research has shown success in the use of generic (dynamic) resistance training interventions for patients affected by head and neck cancer. However, this approach could be optimized with the use of novel training methods.The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.
Read the detailed description
Background and Rationale
Patients who receive radiation therapy for head and neck cancer treatment are susceptible to side-effects such as a significant loss in body mass and a loss of muscle mass (cancer cachexia) compared to pre-treatment. In addition, radiation therapy treatment may cause cancer-related fatigue and a reduction in overall physical function and health-related quality of life. Some research has shown success in the use of generic (dynamic exercise) resistance training interventions when applied for head and neck cancer survivors. Typically, when the correct training principals are adhered to in healthy populations (i.e. progressive overload, specificity, variation, rest/recovery), muscle strength and muscle mass are effectively enhanced. However, these training variables may be less effective in eliciting positive outcomes in clinical populations in that they are less effective in increasing muscle mass and muscle strength. Exercise is beneficial for people affected by all cancer types, but resistance training may be particularly beneficial for people who have completed radiation therapy treatment for head and neck cancer. Alternative modalities may provide superior improvements in muscle strength and muscle mass. Therefore, further research is warranted to investigate optimized resistance training prescription in head and neck cancer patients.
Research Question \& Objectives
The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.
Methods
Head and neck cancer survivors who have completed radiation therapy ≥ 1 month and ≤ 1 year from enrollment will be randomly allocated to one of two treatment arms: conventional (active control) and accentuated eccentric loading + electromyostimulation. Participants will be assessed before and after the intervention for patient-reported outcomes, neuromuscular function and fatigability in response to whole-body exercise.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Accentuated eccentric loading + electromyostimulation, Conventional resistance training
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accentuated eccentric loading + electromyostimulationBehavioural
An innovative training intervention to optimize muscle strength and muscle mass
Conventional resistance trainingBehavioural
A conventional approach to resistance training
| Study group | Role | What they receive |
|---|---|---|
| Accentuated eccentric loading + electromyostimulation | Experimental | This group will undertake a supervised 12-week intervention involving accentuated eccentric loading and electromyostimulation of the knee extensors, dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training. Receives: Behavioral: Accentuated eccentric loading + electromyostimulation |
| Traditional resistance training | Active comparator | This group with undertake a supervised 12-week intervention involving volume matched dynamic resistance training of the knee extensors, and dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training. Receives: Behavioral: Conventional resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isometric Force in the Knee Extensors
A change in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention
Assessment of change in Muscle Cross-Sectional Area
ultrasound measurement of the vastus lateralis and rectus femoris
Measured: Baseline and after the 12-week intervention
Secondary outcomes (10)
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Self-report questionnaire for the assessment of cancer-related fatigue. This scale is between a possible raw score of 0 - 52, where the higher the number, the better the outcome.
Measured: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale
Self-report questionnaire for the assessment of quality of life. This scale is between a possible 0 - 144 points, where the higher the number the better the outcome. There are 5 individual sub scales that measure physical-, social-, emotional-, and functional well-being as well as head and neck specific concerns.
Measured: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Voluntary Activation
A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test
Measured: Baseline and after the 12-week intervention
Potentiated Twitch Force
A reduction in potentiated quadriceps twitch force measured before, before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention
Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test
Measured: Baseline and after the 12-week intervention
Voluntary Electromyography (EMG)
Root mean square of the EMG signal during an MVC, measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention
Time to volitional exhaustion
Time to task failure during an intermittent cycling test
Measured: Baseline and after the 12-week intervention
Body mass (kg)
Measured: Baseline and after the 12-week intervention
Estimated body fat %
Estimated using skin folds
Measured: Baseline and after the 12-week intervention
Body mass index
Body mass / (height * height)
Measured: Baseline and after the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start31 Mar 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2020 (estimated)
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 CalgaryThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Millet, University of Calgary
- Investigators
- Gui Millet, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013178
- Sponsor's protocol ID
- HREBA.CC-16-0744
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04013178
- Acronym / sponsor ID
- HREBA.CC-16-0744
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2020 (estimated)
- First posted
- 9 Jul 2019 (actual)
- 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.
People who receive radiation therapy for head and neck cancer (HNC) can experience side-effects which include a significant loss in body mass and a loss of muscle mass (cancer cachexia). Some research has shown success in the use of generic (dynamic) resistance training interventions for patients affected by head and neck cancer. However, this approach could be optimized with the use of novel training methods.The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.
Detailed description
Background and Rationale
Patients who receive radiation therapy for head and neck cancer treatment are susceptible to side-effects such as a significant loss in body mass and a loss of muscle mass (cancer cachexia) compared to pre-treatment. In addition, radiation therapy treatment may cause cancer-related fatigue and a reduction in overall physical function and health-related quality of life. Some research has shown success in the use of generic (dynamic exercise) resistance training interventions when applied for head and neck cancer survivors. Typically, when the correct training principals are adhered to in healthy populations (i.e. progressive overload, specificity, variation, rest/recovery), muscle strength and muscle mass are effectively enhanced. However, these training variables may be less effective in eliciting positive outcomes in clinical populations in that they are less effective in increasing muscle mass and muscle strength. Exercise is beneficial for people affected by all cancer types, but resistance training may be particularly beneficial for people who have completed radiation therapy treatment for head and neck cancer. Alternative modalities may provide superior improvements in muscle strength and muscle mass. Therefore, further research is warranted to investigate optimized resistance training prescription in head and neck cancer patients.
Research Question \& Objectives
The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.
Methods
Head and neck cancer survivors who have completed radiation therapy ≥ 1 month and ≤ 1 year from enrollment will be randomly allocated to one of two treatment arms: conventional (active control) and accentuated eccentric loading + electromyostimulation. Participants will be assessed before and after the intervention for patient-reported outcomes, neuromuscular function and fatigability in response to whole-body exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Accentuated eccentric loading + electromyostimulation | Experimental | Behavioral: Accentuated eccentric loading + electromyostimulationThis group will undertake a supervised 12-week intervention involving accentuated eccentric loading and electromyostimulation of the knee extensors, dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training. |
| Traditional resistance training | Active comparator | Behavioral: Conventional resistance trainingThis group with undertake a supervised 12-week intervention involving volume matched dynamic resistance training of the knee extensors, and dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a verified clinical diagnosis of head and neck cancer (stage I-IV) with the primary tumor in the oral cavity, pharynx, larynx, paranasal sinuses, or salivary glands.
- received radiation therapy ± concomitant chemotherapy
- able to walk without assistance
- received Canadian Society for Exercise Physiology-Certified Exercise Physiologist (CSEP-CEP) approval via The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and/or physician approval
- willing/able to travel to the University of Calgary (Calgary, AB).
Key exclusion criteria (3 listed)
- comorbidities that could confound the ability to participate in laboratory tests (e.g. other malignancies, neuromuscular, musculoskeletal or vascular conditions affecting the lower extremities, such as radiculopathy or myopathy, (where the research team were consulted for individual cases)
- presence of a percutaneous endoscopic gastrostomy
- unable to follow verbal instructions in English
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 |
|---|---|---|
| Accentuated eccentric loading + electromyostimulationAn innovative training intervention to optimize muscle strength and muscle mass | Behavioural | Accentuated eccentric loading + electromyostimulation |
| Conventional resistance trainingA conventional approach to resistance training | Behavioural | Traditional resistance training |
Primary outcome
Maximal Isometric Force in the Knee Extensors
Time frame: Baseline and after the 12-week intervention
A change in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.
Assessment of change in Muscle Cross-Sectional Area
Time frame: Baseline and after the 12-week intervention
ultrasound measurement of the vastus lateralis and rectus femoris
10 secondary outcomes
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Time frame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale
Time frame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Voluntary Activation
Time frame: Baseline and after the 12-week intervention
Potentiated Twitch Force
Time frame: Baseline and after the 12-week intervention
Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
Time frame: Baseline and after the 12-week intervention
Voluntary Electromyography (EMG)
Time frame: Baseline and after the 12-week intervention
Time to volitional exhaustion
Time frame: Baseline and after the 12-week intervention
Body mass (kg)
Time frame: Baseline and after the 12-week intervention
Estimated body fat %
Time frame: Baseline and after the 12-week intervention
Body mass index
Time frame: Baseline and after the 12-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- 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.
Gui Millet, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accentuated eccentric loading + electromyostimulation and Conventional resistance training in people with Head and Neck Neoplasms, run by University of Calgary 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2019. 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?
Results are not available in the source record.
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?
Maximal Isometric Force in the Knee Extensors (time frame: Baseline and after the 12-week intervention). The study lists 2 primary outcomes in all. 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 11 Jul 2019.