This trial uses blood tests and questionnaires to study how well participants with head and neck cancer 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.
Additional locations may be listed on ClinicalTrials.gov for NCT03010150.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Eileen H Shinn
Phone: 713-745-0870
PRIMARY OBJECTIVES:
I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after 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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorEileen H Shinn
