Exercise After Radiation for Head & Neck Cancer

NCT ID: NCT04013178

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2020-06-26

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Accentuated eccentric loading + electromyostimulation

Intervention Type: BEHAVIORAL

An innovative training intervention to optimize muscle strength and muscle mass

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.

Group Type: ACTIVE_COMPARATOR

Conventional resistance training

Intervention Type: BEHAVIORAL

A conventional approach to resistance training

Interventions

Accentuated eccentric loading + electromyostimulation

An innovative training intervention to optimize muscle strength and muscle mass

Intervention Type: BEHAVIORAL

Conventional resistance training

A conventional approach to resistance training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Guillaume Millet

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gui Millet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Faculty of Kinesiology

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

HREBA.CC-16-0744

Identifier Type: -

Identifier Source: org_study_id