Studying Blood Tests and Questionnaires to Understand How People With Advanced Head and Neck Cancer Follow Swallowing Exercise Plans
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
471
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying how well people with head and neck cancer that has spread to other parts of the body follow swallowing exercises after radiation treatment. The study aims to understand if certain immune system proteins called cytokines influence side effects or risk for future disease. Questionnaires help explore reasons why participants may or may not stick to the exercise routine after therapy.
Participants provide blood samples before and six months after radiation therapy to measure cytokines and other markers. They complete questionnaires either at home, in clinic, or online before radiation starts and around the same time as blood collection. The study also looks at social support, coping, depression, fatigue, and pain, and explores genetic markers related to swallowing problems.
During the study, participants are followed for up to two years after finishing the questionnaires and blood tests. Researchers analyze adherence to swallowing exercises, illness perceptions, and the effects of social support over six months. The study includes regular assessments through blood tests and questionnaires to understand the participants health and behavior over time.
CONDITIONS
Brief Title
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
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Are planned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or unknown primary cancer with cervical metastases
Are stage II-IVb for non-HPV-related oropharyngeal cancer
Have HPV-related oropharynx cancer that is T1 with nodal involvement and no distant metastasis, or at least T2 with no distant metastasis
Are stage II-IVb for laryngeal cancer
Are stage I-IVb for hypopharyngeal cancer
Are stage I-IVb for nasopharyngeal cancer
Have stage I-III unknown primary cancer with cervical metastases
You will not qualify if you...
Have other cancer diagnoses except non-melanoma skin cancer
Have had treatment for previous head and neck cancer or radiation to the head and neck
Have a history of previous head and neck surgery excluding biopsy, tonsillectomy, or tracheotomy
Have current oropharyngeal swallowing difficulties unrelated to cancer diagnosis such as from neurogenic disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Diagnostic Evaluation
Duration - Up to 2 weeks before radiation therapy
Participants provide blood samples and complete questionnaires prior to receiving radiation therapy to assess baseline measures.
1 visit (in-person or remote) for blood sample and questionnaires
Long-term Monitoring
Duration - Up to 2 years after radiation therapy
Participants provide blood samples and complete questionnaires at 6 months after radiation therapy and are followed up periodically for up to 2 years to monitor adherence and health outcomes.
1 visit at 6 months for blood sample and questionnaires, periodic follow-ups up to 2 years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Iterative Patient Testing of a Stimuli-Responsive Swallowing Activity Sensor to Promote Extended User Engagement During the First Year After Radiation: Multiphase Remote and In-Person Observational Cohort Study.
Eileen H Shinn, Adam S Garden, Susan K Peterson...