NCT03010150 Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
| NCT ID | NCT03010150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Carcinoma of Unknown Primary |
| Study Type | OBSERVATIONAL |
| Enrollment | 471 participants |
| Start Date | 2016-12-29 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 471 participants in total. It began in 2016-12-29 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.
Eligibility Criteria
Inclusion Criteria: * Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases * Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer * Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis * Are stage II-IVb for laryngeal cancer * Are stage I-IVb for hypopharyngeal * Are stage I-IVb for nasopharyngeal cancer * Have stage I-III unknown primary cancer with cervical Exclusion Criteria: * Have other cancer diagnoses, except non-melanoma skin cancer * 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 and/or tonsillectomy and/or tracheotomy) * Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
Contact & Investigator
Eileen H Shinn
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03010150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma of Unknown Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03010150 currently recruiting?
Yes, NCT03010150 is actively recruiting participants. Visit ClinicalTrials.gov or contact M.D. Anderson Cancer Center to inquire about joining.
Where is the NCT03010150 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03010150 clinical trial?
NCT03010150 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Eileen H Shinn at M.D. Anderson Cancer Center. The trial plans to enroll 471 participants.