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

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ClinicalTrials.gov Identifier: NCT01781468
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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)
Actual Enrollment : 328 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
Actual Study Start Date : June 2013
Actual Primary Completion Date : May 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Armodafinil

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. The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. [ Time Frame: 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



Secondary Outcome Measures :
  1. 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. [ Time Frame: Up to 4 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 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome

  2. Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8 [ Time Frame: Up to 8 weeks ]
    The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.

  3. Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8 [ Time Frame: Up to 8 weeks ]
    Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.

  4. 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 [ Time Frame: Up to 8 weeks ]
    The 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


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781468


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Alyx B. Porter Umphrey, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Alliance for Clinical Trials in Oncology:
Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2018

More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01781468    
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    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Fatigue
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
 Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action