Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Study Description

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Brief Summary:

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

Condition or disease	Intervention/treatment	Phase
Fatigue	Drug: armodafinil 150 mg; Other: Placebo; Drug: armodafinil 250 mg	Phase 3

Detailed Description:

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

The secondary objectives of the study are listed below.

1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the relationship of fatigue and cognitive difficulties.

Patients will receive armodafinil or placebo for a total of 8 weeks.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	330 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Supportive Care
Official Title:	A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
Study Start Date :	June 2013
Estimated Primary Completion Date :	May 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm I; Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.	Drug: armodafinil 150 mg; given orally
Placebo Comparator: Arm II; Patients receive placebo orally every day in the morning for 8 weeks.	Other: Placebo; given orally
Experimental: Arm III; Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.	Drug: armodafinil 250 mg; given orally

Outcome Measures

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Primary Outcome Measures :

1. Response rate in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures :

1. Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ]
2. Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ]
3. Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ]
4. Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
• >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
• Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
• Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
• Ability to complete questionnaire(s) by themselves or with assistance
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
• Provide informed written consent
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
• Stable dose of corticosteroid >= 14 days prior to registration

Contacts and Locations

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Contacts

Contact: Alyx B. Porter Umphrey, MD	(507) 266-5230

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Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

Study Chair:	Alyx B. Porter Umphrey, MD	Mayo Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT01781468 History of Changes
Other Study ID Numbers:	A221101; N10C3; NCI-2012-02020 ( Registry Identifier: Clinical Trial Reporting Program ); U10CA037404 ( U.S. NIH Grant/Contract ); U10CA037447 ( U.S. NIH Grant/Contract ); UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted:	February 1, 2013
Last Update Posted:	April 9, 2018
Last Verified:	April 2018

Additional relevant MeSH terms:

Fatigue; Signs and Symptoms; Armodafinil; Modafinil; Wakefulness-Promoting Agents	Central Nervous System Stimulants; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action