Exercise After Radiation for Head & Neck Cancer

Not Applicable

• Conditions: Head and Neck Neoplasms
• Interventions: Behavioral: Accentuated eccentric loading + electromyostimulation; Behavioral: Conventional resistance training

• Registration Number: NCT04013178
• Lead Sponsor: University of Calgary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-31
• Primary Completion: 2019-06-26
• Status Verified: 2019-07
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11
• Study Completion: 2020-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accentuated eccentric loading + electromyostimulation	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.
Traditional resistance training	Conventional 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.

Primary Outcome Measures

Name	Time	Method
Maximal Isometric Force in the Knee Extensors	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	Baseline and after the 12-week intervention	ultrasound measurement of the vastus lateralis and rectus femoris

Secondary Outcome Measures

Name	Time	Method
Body mass (kg)	Baseline and after the 12-week intervention
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale	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.
Potentiated Twitch Force	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	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
Estimated body fat %	Baseline and after the 12-week intervention	Estimated using skin folds
Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale	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.
Time to volitional exhaustion	Baseline and after the 12-week intervention	Time to task failure during an intermittent cycling test
Voluntary Electromyography (EMG)	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.
Body mass index	Baseline and after the 12-week intervention	Body mass / (height \* height)
Voluntary Activation	Baseline and after the 12-week intervention	A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test

Trial Locations

Locations (1)

Faculty of Kinesiology; 🇨🇦 Calgary, Alberta, Canada