NCT01781468|CompletedPhase 3ResultsDMC

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

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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6 other identifiers

A221101N10C3NCI-2012-02020U10CA037404U10CA037447UG1CA189823

Study Type

interventional

Target

328

Locations

1 country

Sites

365

Timeline

RegisteredFeb 2013

StartedJun 2013

CompletionDec 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

328

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2013

Longer than P75 for phase_3

Geographic Reach

1 country

365 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

First Submitted

Initial submission to the registry

January 29, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

June 21, 2013

Completed

5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed

5 months until next milestone

Results Posted

Study results publicly available

May 7, 2020

Completed

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.9 years

First QC Date

January 29, 2013

Results QC Date

April 9, 2020

Last Update Submit

January 14, 2025

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

The Number of Participants With a Response 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). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
At 8 weeks

Secondary Outcomes (4)

Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.
Up to 4 weeks
Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8
Up to 8 weeks
Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8
Up to 8 weeks
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0
Up to 8 weeks

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.

Drug: armodafinil 150 mg

Arm II

PLACEBO COMPARATOR

Patients receive placebo orally every day in the morning for 8 weeks.

Other: Placebo

Arm III

EXPERIMENTAL

Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.

Drug: armodafinil 250 mg

Interventions

armodafinil 150 mgDRUG

given orally

Arm I

PlaceboOTHER

given orally

Arm II

armodafinil 250 mgDRUG

given orally

Arm III

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.