Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03010150 | RECRUITING | Carcinoma of Unknown Primary

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

M.D. Anderson Cancer Center

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.

Condition or disease

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

Metastatic Malignant Neoplasm in the Uterine Cervix

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

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

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

Stage I Hypopharyngeal Carcinoma AJCC v8

Stage I Nasopharyngeal Carcinoma AJCC v8

Stage II Hypopharyngeal Carcinoma AJCC v8

Stage II Laryngeal Cancer AJCC v8

Stage II Nasopharyngeal Carcinoma AJCC v8

Stage II oropharyngeal (p16-negative) carcinoma AJCC v8

Stage III hypopharyngeal carcinoma AJCC v8

Stage III Laryngeal Cancer AJCC v8

Stage III Nasopharyngeal Carcinoma AJCC v8

Stage III oropharyngeal (p16-negative) carcinoma AJCC v8

Stage IV hypopharyngeal carcinoma AJCC v8

Stage IV Laryngeal Cancer AJCC v8

Stage IV nasopharyngeal carcinoma AJCC v8

Stage IV oropharyngeal (p16-negative) carcinoma AJCC v8

Stage IVA Hypopharyngeal Carcinoma AJCC v8

Stage IVA Laryngeal Cancer AJCC v8

Stage IVA Nasopharyngeal Carcinoma AJCC v8

Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Stage IVB Hypopharyngeal Carcinoma AJCC v8

Stage IVB Laryngeal Cancer AJCC v8

Stage IVB Nasopharyngeal Carcinoma AJCC v8

Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Intervention/treatment

Biospecimen Collection

Questionnaire Administration

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 471 participants
Official Title : Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
Actual Study Start Date : 2016-12-29
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

Location Details

NCT03010150

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030