Status:
WITHDRAWN
Feasibility and Safety of Aerobic Exercise for Head and Neck Cancer Patients
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Head and Neck Neoplasm
Radiotherapy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 patien...
Detailed Description
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 patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04679233
Start Date
February 1 2021
End Date
September 1 2021
Last Update
February 24 2022
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21231