Trial Information

Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy

Questionnaires:

If you decide to take part in this study, before starting radiation therapy, weekly during
radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy, you
will complete 4 questionnaires. Three (3) of the questionnaires will be completed during a
study visit, and the last 1 will be completed at home the next time you come into the
clinic. You will return the questionnaire completed at home to the study doctor at a study
visit. The questionnaires will ask questions about fatigue, any symptoms you may have, and
your sleeping habits. It should take about 30 minutes total to complete all of the
questionnaires each time.

Sleep Diary:

You will complete a sleep diary. The sleep diary will be provided to you before starting
radiation therapy. You will record information in it about your sleep habits, caffeinated
beverages and drugs you may take, the quality of your sleep, and how you feel when you wake
up. You will complete the sleep diary during the 48 hours that you are wearing the
actigraphy watch. You will bring the sleep diary to the clinic every week for the study
doctor to review.

Actigraphy Watch:

You will wear an actigraphy watch on your wrist for 48 hours before starting radiation
therapy, for 48 hours each week during radiation therapy, and again for 48 hours 3-4 weeks
and 6-8 weeks after completing radiation therapy. The actigraphy watch will measure your
activity during the day and night. You will bring the actigraphy watch to the clinic every
week for the study doctor to review.

Saliva Collection:

You will collect a saliva sample four times during the day before starting radiation
therapy, one time during the third and last week of radiation therapy, and again 3-4 weeks
and 6-8 weeks after completing radiation therapy. These samples will be used to measure
levels of neurotransmitters and hormone levels. These are substances which are released in
the body that may affect sleep and the immune system.

Length of Study:

You will remain on study for about 8 weeks after you complete radiation therapy.

This is an investigational study. Up to 20 patients will take part in this study. All will
be enrolled at M.D. Anderson.