Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients

Completed

Conditions studied: Brain Cancer

In brief

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.

Key facts

Study ID

NCT00876499

Run by

M.D. Anderson Cancer Center

People needed

20

Starts

2009-01-01

Expected to finish

2013-12-01

Last updated by the study team

2015-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A new diagnosis of a primary glioma, astrocytoma, oligodendroglioma, oligo-astrocytoma, ependymoma, tanycytic ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma, anaplastic ependymoma
• Radiation therapy as part of the plan of care
• 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.
• Ability to speak, write, and read English
• On corticosteroids at the initiation of radiation therapy.

You may not qualify if…

• Tumors involving the suprasellar region, including the pituitary and hypothalamus
• Cognitive deficits which limit ability to self-report symptoms.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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