Page last updated: 2024-10-31

modafinil and Glioma

modafinil has been researched along with Glioma in 5 studies

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.

Glioma: Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

Research Excerpts

ExcerptRelevanceReference
"To determine whether armodafinil reduces fatigue in patients with HGG and moderate-to-severe fatigue."9.51Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial. ( Brown, PD; Cerhan, JL; Jaeckle, KA; Kizilbash, SH; Kohli, S; Le-Rademacher, J; Liu, H; Loprinzi, CL; McMurray, RP; Mehta, MP; Porter, AB; Sloan, J; Villano, JL, 2022)
"While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study."9.22A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy. ( Alexander, BM; Arvold, ND; Doherty, L; Drappatz, J; Fadul, CE; Gaffey, SC; Hammond, S; Kesari, S; LaFrankie, D; Lee, EQ; Muzikansky, A; Nayak, L; Norden, AD; Pulverenti, J; Reardon, DA; Rinne, ML; Ruland, SF; Smith, KH; Stefanik, J; Wen, PY; Wong, ET, 2016)
" Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = ."9.17The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial. ( Boele, FW; Cleijne, W; de Groot, M; Douw, L; Heimans, JJ; Klein, M; Reijneveld, JC; Taphoorn, MJ; van Thuijl, HF, 2013)
"To determine whether armodafinil reduces fatigue in patients with HGG and moderate-to-severe fatigue."5.51Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial. ( Brown, PD; Cerhan, JL; Jaeckle, KA; Kizilbash, SH; Kohli, S; Le-Rademacher, J; Liu, H; Loprinzi, CL; McMurray, RP; Mehta, MP; Porter, AB; Sloan, J; Villano, JL, 2022)
"While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study."5.22A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy. ( Alexander, BM; Arvold, ND; Doherty, L; Drappatz, J; Fadul, CE; Gaffey, SC; Hammond, S; Kesari, S; LaFrankie, D; Lee, EQ; Muzikansky, A; Nayak, L; Norden, AD; Pulverenti, J; Reardon, DA; Rinne, ML; Ruland, SF; Smith, KH; Stefanik, J; Wen, PY; Wong, ET, 2016)
" Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = ."5.17The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial. ( Boele, FW; Cleijne, W; de Groot, M; Douw, L; Heimans, JJ; Klein, M; Reijneveld, JC; Taphoorn, MJ; van Thuijl, HF, 2013)
"Fatigue is a common and disabling symptom in people with a primary brain tumour (PBT)."2.82Interventions for the management of fatigue in adults with a primary brain tumour. ( Bulbeck, H; Cachia, D; Day, J; Rooney, AG; Tremont Lukats, IW; Wefel, J; Yust-Katz, S, 2022)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's3 (60.00)24.3611
2020's2 (40.00)2.80

Authors

AuthorsStudies
Porter, AB1
Liu, H1
Kohli, S1
Cerhan, JL1
Sloan, J1
McMurray, RP1
Le-Rademacher, J1
Loprinzi, CL1
Villano, JL1
Kizilbash, SH1
Mehta, MP1
Jaeckle, KA1
Brown, PD1
Day, J1
Yust-Katz, S1
Cachia, D1
Wefel, J1
Tremont Lukats, IW1
Bulbeck, H1
Rooney, AG1
Boele, FW1
Douw, L1
de Groot, M1
van Thuijl, HF1
Cleijne, W1
Heimans, JJ1
Taphoorn, MJ1
Reijneveld, JC1
Klein, M1
Lee, EQ1
Muzikansky, A1
Drappatz, J1
Kesari, S1
Wong, ET1
Fadul, CE1
Reardon, DA1
Norden, AD1
Nayak, L1
Rinne, ML1
Alexander, BM1
Arvold, ND1
Doherty, L1
Stefanik, J1
LaFrankie, D1
Ruland, SF1
Pulverenti, J1
Smith, KH1
Gaffey, SC1
Hammond, S1
Wen, PY1
Gehring, K1
Patwardhan, SY1
Collins, R1
Groves, MD1
Etzel, CJ1
Meyers, CA1
Wefel, JS1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (NuvigilĀ®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma[NCT01781468]Phase 3328 participants (Actual)Interventional2013-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8

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. (NCT01781468)
Timeframe: Up to 8 weeks

Interventionunits on a scale (Median)
Arm I (150 mg Armodafinil)0.0
Arm II (250 mg Armodafinil)0.3
Arm III (Placebo)0.0

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.

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 (NCT01781468)
Timeframe: Up to 4 weeks

InterventionParticipants (Count of Participants)
Arm I (150 mg Armodafinil)37
Arm II (250 mg Armodafinil)31
Arm III (Placebo)30

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

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 (NCT01781468)
Timeframe: Up to 8 weeks

InterventionParticipants (Count of Participants)
Arm I (150 mg Armodafinil)6
Arm II (250 mg Armodafinil)8
Arm III (Placebo)3

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" (NCT01781468)
Timeframe: At 8 weeks

InterventionParticipants (Count of Participants)
Arm I (150 mg Armodafinil)29
Arm II (250 mg Armodafinil)27
Arm III (Placebo)29

Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8

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. (NCT01781468)
Timeframe: Up to 8 weeks

,,
Interventionunits on a scale (Median)
Baseline to Week 4Baseline to Week 8
Arm I (150 mg Armodafinil)2.04.0
Arm II (250 mg Armodafinil)0.53.0
Arm III (Placebo)2.02.0

Reviews

1 review available for modafinil and Glioma

ArticleYear
Interventions for the management of fatigue in adults with a primary brain tumour.
    The Cochrane database of systematic reviews, 2022, 09-12, Volume: 9

    Topics: Adult; Brain Neoplasms; Dextroamphetamine; Fatigue; Glioma; Humans; Modafinil

2022

Trials

4 trials available for modafinil and Glioma

ArticleYear
Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial.
    JAMA oncology, 2022, Feb-01, Volume: 8, Issue:2

    Topics: Adult; Aged; Benzhydryl Compounds; Double-Blind Method; Fatigue; Female; Glioma; Humans; Male; Middl

2022
The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial.
    Neuro-oncology, 2013, Volume: 15, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Brain Neoplasms; Cognition Disorders; Cross-Ov

2013
A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy.
    Neuro-oncology, 2016, Volume: 18, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Double-Blind Method; Fatigue; Female; Glioma;

2016
A randomized trial on the efficacy of methylphenidate and modafinil for improving cognitive functioning and symptoms in patients with a primary brain tumor.
    Journal of neuro-oncology, 2012, Volume: 107, Issue:1

    Topics: Adult; Benzhydryl Compounds; Brain Neoplasms; Central Nervous System Stimulants; Cognition Disorders

2012