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

This study is currently recruiting participants.

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Contacts and Locations

Verified August 2017 by Alliance for Clinical Trials in Oncology

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01781468

First received: January 29, 2013

Last updated: August 15, 2017

Last verified: August 2017

History of Changes

Purpose

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	Intervention	Phase
Fatigue	Drug: armodafinil 150 mg Other: Placebo Drug: armodafinil 250 mg	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Fatigue

Drug Information available for: Modafinil Armodafinil

Genetic and Rare Diseases Information Center resources: Glioma

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:

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:

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 ]
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 ]
Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ]
Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ]


Estimated Enrollment:	330
Study Start Date:	June 2013
Estimated Primary Completion Date:	May 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781468

Contacts


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

Show 311 Study Locations

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


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 )
Study First Received:	January 29, 2013
Last Updated:	August 15, 2017

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

ClinicalTrials.gov processed this record on August 22, 2017

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