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RecruitingNCT03010150

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Sponsor

M.D. Anderson Cancer Center

Enrollment

471 participants

Start Date

Dec 29, 2016

Study Type

OBSERVATIONAL

Conditions

Carcinoma of Unknown PrimaryMetastatic Malignant Neoplasm in the Uterine CervixClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Metastatic Head and Neck CarcinomaStage III Nasopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage I Hypopharyngeal Carcinoma AJCC v8Stage I Nasopharyngeal Carcinoma AJCC v8Stage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Nasopharyngeal Carcinoma AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Nasopharyngeal Carcinoma AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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)

Interventions

PROCEDUREBiospecimen Collection

Provide blood samples

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03010150

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