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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVA Laryngeal Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Nasopharyngeal Carcinoma AJCC v8; Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage IVA Nasopharyngeal Carcinoma AJCC v8; Metastatic Malignant Neoplasm in the Uterine Cervix; Stage IVB Laryngeal Cancer AJCC v8; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Hypopharyngeal Carcinoma AJCC v8; Stage IVA Hypopharyngeal Carcinoma AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage II Laryngeal Cancer AJCC v8; Stage I Nasopharyngeal Carcinoma AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Nasopharyngeal Carcinoma AJCC v8; Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage I Hypopharyngeal Carcinoma AJCC v8; Metastatic Head and Neck Carcinoma; Carcinoma of Unknown Primary; Stage IV Nasopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage II Hypopharyngeal Carcinoma AJCC v8; Stage II Nasopharyngeal Carcinoma AJCC v8; Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage III Hypopharyngeal Carcinoma AJCC v8

Treatments: Other: Questionnaire Administration; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03010150

2016-0597 (Other Identifier)

NCI-2018-01260 (Registry Identifier)

R21DE019954 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after the end of radiation.

II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness perceptions are mediated by pro-inflammatory cytokines.

III. To determine whether social support moderates the impact of coping on appraisal of coping.

SECONDARY OBJECTIVES:

I. As a secondary aim, to determine the feasibility and utility of cardiac impedance pre-ejection period measurement as a corollary measure for depression and distress.

II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction which has developed by the 6-month follow-up.

OUTLINE:

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.

After completion of study, participants are followed up periodically for up to 2 years.

Enrollment: 471 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

471 participants in 1 patient group

Observational (blood tests, questionnaires)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Questionnaire Administration