Status
Conditions
Treatments
About
This goal of this research study is to learn more about fatigue, sleep quality, and other symptoms in patients with primary brain tumors who are being treated with radiation therapy.
Objectives:
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
20 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal