Clinical trial NCT04013178: Exercise After Radiation for Head & Neck Cancer
Official title: Eccentric Exercise and Electromyostimulation to Improve Muscle Strength and Muscle Mass After Radiation Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximal Isometric Force in the Knee Extensors
timeFrame: Baseline and after the 12-week intervention
measure: Assessment of change in Muscle Cross-Sectional Area
timeFrame: Baseline and after the 12-week intervention
Secondary outcomes:
measure: Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
timeFrame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
measure: Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale
timeFrame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up
measure: Voluntary Activation
timeFrame: Baseline and after the 12-week intervention
measure: Potentiated Twitch Force
timeFrame: Baseline and after the 12-week intervention
measure: Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
timeFrame: Baseline and after the 12-week intervention
measure: Voluntary Electromyography (EMG)
timeFrame: Baseline and after the 12-week intervention
measure: Time to volitional exhaustion
timeFrame: Baseline and after the 12-week intervention
measure: Body mass (kg)
timeFrame: Baseline and after the 12-week intervention
measure: Estimated body fat %
timeFrame: Baseline and after the 12-week intervention
measure: Body mass index
timeFrame: Baseline and after the 12-week intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Faculty of Kinesiology
state: Alberta
Study officials:
affiliation: University of Calgary
name: Gui Millet, PhD
role: PRINCIPAL_INVESTIGATOR
References: