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Exercise After Radiation for Head & Neck Cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Neoplasms | Behavioral: Accentuated eccentric loading + electromyostimulation Behavioral: Conventional resistance training | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants are assigned to one of two groups in parallel for the duration of the study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer |
| Actual Study Start Date : | March 31, 2017 |
| Actual Primary Completion Date : | June 26, 2019 |
| Estimated Study Completion Date : | June 26, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Accentuated eccentric loading + electromyostimulation
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.
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Behavioral: Accentuated eccentric loading + electromyostimulation
An innovative training intervention to optimize muscle strength and muscle mass
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Active Comparator: Traditional resistance training
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.
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Behavioral: Conventional resistance training
A conventional approach to resistance training
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- 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
- 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 ]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.
- 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 ]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.
- Voluntary Activation [ Time Frame: Baseline and after the 12-week intervention ]A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test
- Potentiated Twitch Force [ Time Frame: Baseline and after the 12-week intervention ]A reduction in potentiated quadriceps twitch force measured before, before, during and after an intermittent cycling test.
- Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude [ Time Frame: Baseline and after the 12-week intervention ]evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test
- Voluntary Electromyography (EMG) [ Time Frame: Baseline and after the 12-week intervention ]Root mean square of the EMG signal during an MVC, measured before, during and after an intermittent cycling test.
- Time to volitional exhaustion [ Time Frame: Baseline and after the 12-week intervention ]Time to task failure during an intermittent cycling test
- Body mass (kg) [ Time Frame: Baseline and after the 12-week intervention ]
- Estimated body fat % [ Time Frame: Baseline and after the 12-week intervention ]Estimated using skin folds
- Body mass index [ Time Frame: Baseline and after the 12-week intervention ]Body mass / (height * height)
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
| Canada, Alberta | |
| Faculty of Kinesiology | |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Principal Investigator: | Gui Millet, PhD | University of Calgary |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 5, 2019 | ||||
| First Posted Date ICMJE | July 9, 2019 | ||||
| Last Update Posted Date | July 11, 2019 | ||||
| Actual Study Start Date ICMJE | March 31, 2017 | ||||
| Actual Primary Completion Date | June 26, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exercise After Radiation for Head & Neck Cancer | ||||
| Official Title ICMJE | Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer | ||||
| Brief 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). 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants are assigned to one of two groups in parallel for the duration of the study Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Head and Neck Neoplasms | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
22 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 26, 2020 | ||||
| Actual Primary Completion Date | June 26, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04013178 | ||||
| Other Study ID Numbers ICMJE | HREBA.CC-16-0744 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Guillaume Millet, University of Calgary | ||||
| Study Sponsor ICMJE | University of Calgary | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Calgary | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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