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NCT00876499 · ClinicalTrials.gov registry record
Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 20
- Enrollment target
NCT00876499: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00876499 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00876499 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-01 |
| Est. Completion | 2013-12 |
What the finished NCT00876499 record still lists
NCT00876499 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Questionnaire is the first listed.
NCT00876499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00876499 about?
NCT00876499 is a clinical study titled "Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients". 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 t...
What is the current status of trial NCT00876499?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2009-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00876499?
The interventions under investigation include: Questionnaire (BEHAVIORAL).
Who is sponsoring clinical trial NCT00876499?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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