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A total of 8 questionnaires regarding fatigue taking approximately 30 minutes each, given before radiation therapy, weekly during, and after completion.

Questionnaire

Mark R. Gilbert

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.

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.

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

Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy

M.D. Anderson Cancer Center

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Temozolomide

Palonosetron

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)

Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.

Palonosetron (PALO)

Mary Lou Affronti, RN, MSN, ANP

1. Purpose and objective:

1. To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ).
2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ
3. To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ.

2. Study activities and Population group: We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty subjects with gliomas will participate.

3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type and the most severe grade experienced. The complete response rate, defined as the proportion of patients with no emetic episode or use of rescue medication while receiving radiation and concomitant temozolomide, will be estimated with a 95% confidence interval.

We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron approximately 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. After the start of radiation the type of rescue medication will be up to the investigator's discretion (however given the results of recent published phase II study by Navari et. al. we recommend using olanzapine for rescue medication). All patients will be given written informed consent.

Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients Receiving Standard Radiotherapy and Concomitant Temozolomide

The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.

The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).

The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.

Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) \* 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.

Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) \* 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.

Eisai Inc.

Duke University

The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.

Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)

Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.

Age, Continuous

Sex: Female, Male

Mary Lou Affronti

Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity

Week 1 of XRT and TMZ (n=38)

Week 2 of XRT and TMZ (n=38)

Week 3 of XRT and TMZ (n=38)

Week 4 of XRT and TMZ (n=38)

Week 5 of XRT and TMZ (n=36)

Week 6 of XRT and TMZ (n=34)

Overall (across weeks 1-6 of XRT and TMZ) (N=34)

Complete Response

Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment

Week 5 of XRT and TMZ (n=35)

Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)

Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients	NCT00876499	Brain Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide	NCT00900757	Malignant Gliom...	Palonosetron (P...	18 Years - 90 Years	Duke University

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