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Exercise After Radiation for Head & Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Accentuated eccentric loading + electromyostimulation
Conventional resistance training
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Kinesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accentuated eccentric loading + electromyostimulation

Traditional resistance training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Assessment of change in Muscle Cross-Sectional Area
ultrasound measurement of the vastus lateralis and rectus femoris

Secondary Outcome Measures

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.
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.
Voluntary Activation
A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test
Potentiated Twitch Force
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
evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test
Voluntary Electromyography (EMG)
Root mean square of the EMG signal during an MVC, measured before, during and after an intermittent cycling test.
Time to volitional exhaustion
Time to task failure during an intermittent cycling test
Body mass (kg)
Estimated body fat %
Estimated using skin folds
Body mass index
Body mass / (height * height)

Full Information

First Posted
July 5, 2019
Last Updated
July 9, 2019
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04013178
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accentuated eccentric loading + electromyostimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional resistance training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Accentuated eccentric loading + electromyostimulation
Intervention Description
An innovative training intervention to optimize muscle strength and muscle mass
Intervention Type
Behavioral
Intervention Name(s)
Conventional resistance training
Intervention Description
A conventional approach to resistance training
Primary Outcome Measure Information:
Title
Maximal Isometric Force in the Knee Extensors
Description
A change in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.
Time Frame
Baseline and after the 12-week intervention
Title
Assessment of change in Muscle Cross-Sectional Area
Description
ultrasound measurement of the vastus lateralis and rectus femoris
Time Frame
Baseline and after the 12-week intervention
Secondary Outcome Measure Information:
Title
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Description
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.
Time Frame
Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Title
Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale
Description
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 Frame
Baseline to after the 12-week intervention, at 6 month and 12 month follow up
Title
Voluntary Activation
Description
A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test
Time Frame
Baseline and after the 12-week intervention
Title
Potentiated Twitch Force
Description
A reduction in potentiated quadriceps twitch force measured before, before, during and after an intermittent cycling test.
Time Frame
Baseline and after the 12-week intervention
Title
Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
Description
evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test
Time Frame
Baseline and after the 12-week intervention
Title
Voluntary Electromyography (EMG)
Description
Root mean square of the EMG signal during an MVC, measured before, during and after an intermittent cycling test.
Time Frame
Baseline and after the 12-week intervention
Title
Time to volitional exhaustion
Description
Time to task failure during an intermittent cycling test
Time Frame
Baseline and after the 12-week intervention
Title
Body mass (kg)
Time Frame
Baseline and after the 12-week intervention
Title
Estimated body fat %
Description
Estimated using skin folds
Time Frame
Baseline and after the 12-week intervention
Title
Body mass index
Description
Body mass / (height * height)
Time Frame
Baseline and after the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gui Millet, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Kinesiology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise After Radiation for Head & Neck Cancer

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