Feasibility and Safety of Aerobic Exercise for Head and Neck Cancer Patients
NCT ID: NCT04679233
Last Updated: 2022-02-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2021-02-28
Study Completion Date
2021-09-30
Brief Summary
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Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).
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Detailed Description
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Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients, is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis.
Based on the evidence, the aerobic exercise prescription for those who provide informed consent will consist of 10 intervals of intensity, and 10 intervals at rest. Each interval of intensity will be 1 minutes long and each rest period will be 1 minute long, and there will be a five-minute warm-up and five-minute cool down of easy pedaling for a total of 30 minutes. Participants will complete two sessions per week, and there will be at least one business day in between each session, for a total of 10 total exercise sessions. The total study duration will be less than 35 days.
The supervised prescribed HIIE intervention will be performed on a stationary cycle ergometer. A cycle ergometer is preferred for safety reasons since it requires less gross motor coordination than might be required with a treadmill. To assist in establishing safety (primary aim), the study participants heart rate will be continually monitored by a clinician during the exercise, guiding them to keep their heart rate within their specifically calculated 80-95% of their maximum HR during the periods of intensity.
The investigators will compare outcomes at baseline with outcomes at the end of the 5-week study period.
Based on the evidence, the aerobic exercise prescription for those who provide informed consent will consist of 10 intervals of intensity, and 10 intervals at rest. Each interval of intensity will be 1 minutes long and each rest period will be 1 minute long, and there will be a five-minute warm-up and five-minute cool down of easy pedaling for a total of 30 minutes. Participants will complete two sessions per week, and there will be at least one business day in between each session, for a total of 10 total exercise sessions. The total study duration will be less than 35 days.
The supervised prescribed HIIE intervention will be performed on a stationary cycle ergometer. A cycle ergometer is preferred for safety reasons since it requires less gross motor coordination than might be required with a treadmill. To assist in establishing safety (primary aim), the study participants heart rate will be continually monitored by a clinician during the exercise, guiding them to keep their heart rate within their specifically calculated 80-95% of their maximum HR during the periods of intensity.
The investigators will compare outcomes at baseline with outcomes at the end of the 5-week study period.
Conditions
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Head and Neck Neoplasm
Radiotherapy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Single group pre-test, post-test feasibility and safety study
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Arm 1: Intervention Arm
Arm 1 will receive the aerobic prescription exercise intervention. As this is a feasibility and safety study, there will not be a second arm.
Group Type
EXPERIMENTAL
Prescription aerobic exercise
Intervention Type
OTHER
high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.
Interventions
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Prescription aerobic exercise
high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 18 years of age
* Histologic proof of primary diagnosis of head and neck cancer
* Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months)
* Ability to understand English in order to understand instructions and complete questionnaires
* Willing to participate in the supervised exercise intervention
* In the planning stages of/or actively receiving IMRT
* Must sign study-specific informed consent
* Medical clearance by attending physician
* Histologic proof of primary diagnosis of head and neck cancer
* Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months)
* Ability to understand English in order to understand instructions and complete questionnaires
* Willing to participate in the supervised exercise intervention
* In the planning stages of/or actively receiving IMRT
* Must sign study-specific informed consent
* Medical clearance by attending physician
Exclusion Criteria
* Evidence of distant metastasis prior to enrollment
* Simultaneous primaries or unknown primary
* Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities
* An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions
* Pregnant or lactating women
* Simultaneous primaries or unknown primary
* Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities
* An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions
* Pregnant or lactating women
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Johns Hopkins University
OTHER
Sponsor Role
collaborator
Vanderbilt University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bethany Rhoten, PhD
Role: STUDY_CHAIR
Vanderbilt University
Locations
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Johns Hopkins
Baltimore, Maryland, United States
Site Status
Countries
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United States
References
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Reference Type
BACKGROUND
Silver HJ, Dietrich MS, Murphy BA. Changes in body mass, energy balance, physical function, and inflammatory state in patients with locally advanced head and neck cancer treated with concurrent chemoradiation after low-dose induction chemotherapy. Head Neck. 2007 Oct;29(10):893-900. doi: 10.1002/hed.20607.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201579
Identifier Type: -
Identifier Source: org_study_id
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