Clinical trial · Observational
Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients
Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaire
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Patient Responses to Brief Fatigue Inventory (BFI)
- timeFrame
- BFI at baseline, at each weekly assessment, and again at the post-therapy assessment (3-4 weeks following chemotherapy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
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