Actively Recruiting

Age: 18Years +
All Genders
ID03010150

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

471

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

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

Similar Trials

A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, C...

Stage II Nasopharyngeal Carcinoma AJCC v8

Actively Recruiting

85 locations

Adaptive De-Intensified Radiotherapy Using Circulating Tumor...

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Actively Recruiting

1 location

CYCORE: Cyberinfrastructure for Comparative Effectiveness Re...

Malignant Head and Neck Neoplasm

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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...

https://pubmed.ncbi.nlm.nih.gov/38416544