Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Brain Cancer |
| Purpose: |
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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:
1. The primary objective of this study is to provide preliminary data describing the
severity and change over time in fatigue using the Brief Fatigue Inventory (BFI) during
radiation therapy for patients with primary gliomas.
SECONDARY OBJECTIVES:
1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom
burden as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
and mood using the Profile of Mood States (POMS) during radiation therapy.
2. To assess alterations in circadian rhythms using actigraphy during radiation therapy
and the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI)
and the Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over
time.
3. To explore the association between the levels of salivary hormones (melatonin and
cortisol) and the occurrence of fatigue and symptom burden.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. A new diagnosis of a primary glioma, astrocytoma, oligodendroglioma,
oligo-astrocytoma, ependymoma, tanycytic ependymoma, anaplastic astrocytoma,
anaplastic oligodendroglioma, anaplastic oligo-astrocytoma, anaplastic ependymoma
2. Radiation therapy as part of the plan of care
3. Age >/= 18 years of age. Children are excluded from this study because of differences
in tumor location and biology with differing symptom clusters. A separate study will
be conducted in the future with children.
4. Ability to speak, write, and read English
5. On corticosteroids at the initiation of radiation therapy.
Exclusion Criteria:
1. Tumors involving the suprasellar region, including the pituitary and hypothalamus
2. Cognitive deficits which limit ability to self-report symptoms.
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| NCT ID: |
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NCT00876499 |
| Primary Contact: |
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Principal Investigator
Mark R. Gilbert
UT MD Anderson Cancer Center
Mark R. Gilbert, MD, BS
Phone: 713-745-4621
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| Backup Contact: |
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Terri S. Armstrong, PhD.
Phone: 713-745-4621
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| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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