Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03010150

Conditions

Carcinoma of Unknown Primary

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

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

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

Metastatic Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Questionnaire Administration

Study Details

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.

Conditions

Carcinoma of Unknown Primary

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

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

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

Metastatic Head and Neck Carcinoma

Study ID

NCT03010150

Start date

Dec 29, 2016

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

471 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (blood tests, questionnaires)

Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.

Interventions

Biospecimen Collection

Provide blood samples

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Adherence to swallowing exercises [ Time Frame: Up to 6 months ]
  • Illness perceptions [ Time Frame: Up to 6 months ]
  • Effect of social support on coping [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Eileen H. Shinn

713-745-0870

Principal Investigator:

Eileen H. Shinn

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.