Last updated on February 2018

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer


Brief description of study

The goal of this clinical research study is to learn about the reasons head and neck cancer patients may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments. Researchers also want to learn if certain levels of cytokines affect if participant has side effects and if it puts participant at risk for future disease. Cytokines are proteins that are related to the immune system.

Detailed Study Description

If participant agrees to take part in this study, participant will complete the below study tests at participant's first study visit and about 6 months after participant's radiation treatment.

Questionnaire

Participant will complete a questionnaire (either in the clinic or at home) about how well participant is following the swallowing exercises and how participant has been coping with stress. The questionnaire will also collect information about the disease and personal information about participant, such as participant's age, sex, race, education level, and marital status. This questionnaire should take about 30 minutes to complete. On the Day 1 visit, participant will not complete the part of the questionnaire that asks about participant's swallowing exercises.

If participant prefers to complete the questionnaire online, a separate email will be sent to participant's email address. The email will contain a link to a secure online questionnaire protected by MD Anderson.

Cytokine Blood Tests:

Blood (about 1-2 teaspoons each time) will be drawn to measure the level of cytokines in participant's blood 2 times. These blood samples will be drawn at the same time as other routine blood draws so participant will not have extra needle sticks.

Researchers want to learn 1) if cytokine levels are related to changes in the types of side effects participant may have, such as fatigue and nausea, 2) which patients are at risk for developing permanent swallowing dysfunction after radiation treatment, and 3) which patients are at risk for developing recurrence after treatment.

Researchers will also study participant's genetic code to try to predict cytokine levels or what side effects participant may have. This means researchers may need to store parts of participant's blood for a long time, maybe with no time limit, to complete the genetic testing. However, these samples will only be used for research testing as described in this consent form.

Length of Study:

Participant's active participation in this study will be over after participant completes the 6 month questionnaire and blood draw.

Information from participant's medical record (such as information about participant's disease history, if the disease has gotten worse, any treatment participant receives, and any side effects participant has) will continue to be collected for up to 2 years after participant completes radiation therapy.

This is an investigational study.

Up to 230 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT03010150

Contact Investigators or Research Sites near you

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Eileen H. Shinn, PHD, MS, ...

University of Texas MD Anderson Cancer Center
Houston, TX United States
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Recruitment Status: Open


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