Exercise After Radiation for Head & Neck Cancer

Study Overview
=================
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.

Official Title
-----------------
Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Accentuated eccentric loading + electromyostimulation
* Behavioral: Conventional resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accentuated eccentric loading + electromyostimulation<br>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. | Behavioral: Accentuated eccentric loading + electromyostimulation<br>* An innovative training intervention to optimize muscle strength and muscle mass<br>|
| Active Comparator: Traditional resistance training<br>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. | Behavioral: Conventional resistance training<br>* A conventional approach to resistance training<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after the 12-week intervention | 
| Assessment of change in Muscle Cross-Sectional Area | ultrasound measurement of the vastus lateralis and rectus femoris | Baseline and after the 12-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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 | 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. | Baseline and after the 12-week intervention | 
| Time to volitional exhaustion | Time to task failure during an intermittent cycling test | Baseline and after the 12-week intervention | 
| Body mass (kg) |  | Baseline and after the 12-week intervention | 
| Estimated body fat % | Estimated using skin folds | Baseline and after the 12-week intervention | 
| Body mass index | Body mass / (height * height) | Baseline and after the 12-week intervention |