Global BulletinAll NewsFDA Approval AlertWomen in Oncology
Expert InterviewsAround the PracticeBetween the LinesFace OffFrom All AnglesMeeting of the MindsOncViewPodcastsTraining AcademyTreatment Algorithms with the Oncology BrothersVideos
Conferences
All JournalsEditorial BoardFor AuthorsYear in Review
Frontline ForumSatellite Sessions
CME/CE
Awareness MonthInteractive ToolsNurse Practitioners/Physician's AssistantsPartnersSponsoredSponsored Media
Career CenterSubscribe
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
Spotlight -
  • Radiation Oncology
  • Surgery
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
    • Conferences
    • CME/CE
    • Career Center
    • Subscribe
Advertisement

Armodafinil Does Not Reduce Cancer-Related Fatigue in High-Grade Glioma

February 8, 2022
By Ariana Pelosci
Article

Treatment with armodafinil did not result in a significant difference in cancer-related fatigue between treatment arms for patients with high-grade glioma.

Use of armodafinil (Nuvigil) for patients with high-grade glioma did not help to reduce cancer-related fatigue, according to results from a phase 3 randomized trial (NCT01781468) published in JAMA Oncology.1

Investigators did not note any differences in fatigue reduction between the 150 mg arm (28%; 95% CI, 20%-30%), the 250 mg arm (28%; 95% CI, 19%-38%), and the placebo arm (30%; 95% CI, 21%-40%). A reduction in global fatigue was observed in patients treated with corticosteroids at –0.7 (95% CI, –1.5 to –0.3) compared with nonusers at -1.7 (95% CI, -2.1 to -1.3; P <.001).

“The results of this phase 3 randomized clinical trial, to our knowledge the largest of its kind designed to determine the effect of armodafinil in this setting, are consistent with prior studies regarding the use of armodafinil in this setting. Unlike the study by Page et al,2 this study did not detect any trend toward an improved response for those patients with worse baseline fatigue,” the investigators wrote.

A total of 328 patients were enrolled in this study, 297 of whom were evaluable. Baseline characteristics were well balanced between arms, except for brief fatigue inventory (BFI) usual fatigue level within 24 hours and BFI global fatigue scores. Treatment was completed by 195 patients, with 18% discontinuing due to withdrawal or refusal of continuation of treatment after initiation; this included 18% of patients in the 150 mg arm, 17% in the 250 mg arm , and 18% in the placebo arm. Discontinuation from adverse effects (AEs) occurred in 14% of patients in the 250 mg arm, 8% in 150 mg arm , and 4% in the placebo arm (P = .03).

Patients younger than 60 years experienced a larger mean change in BFI global fatigue score from baseline at –1.5 (95% CI, –2.0 to –1.1) compared with 0.9 (95% CI, –1.6 to –0.6; P = .02) in those who were 60 years or older at .

No statistically significant changes were observed in baseline Linear Analogue Self-Assessment score to week 4 or week 8 between treatment arms. Moreover, within the same time period, patients did not have a significant change in weekly leisure time activity score. A larger reduction in leisure time was seen at the end of week 4 at –3.3 (9% CI, –8.0 to 1.4) than at the end of week 8 at 1.2 (95% CI, –4.4 to 6.8; P = .04).

Additionally, investigators did not observe a major difference between treatment arms in terms of measuring cognitive function from baseline to weeks 4 and 8 Linear Analogue Self-Assessment score

z score change or amount of patients who experienced neurocognitive deterioration. At week 4, 36.6% (95% CI, 30.3%-43.2%) had a decline in cognitive function and 38.6% (95% CI, 31.5%-46.0%) declined at 8 weeks. In total, 37.7% (95% CI, 26.3%-50.2%) of those in the 250 mg arm had a neurocognitive decline at 4-weeks compared with 38.5% (95% CI, 27.7%-50.2%) in the 150 mg arm and 33.8% (95% CI, 23.6%-45.2%) in the placebo arm. At 8 weeks, the decline was 43.1% (95% CI, 30.9%-56.0%) in the placebo arm, 34.4% (95% CI, 22.7%-47.7%) in the 150 mg arm, and 37.9% (95% CI, 25.5%-51.6%) in the 250 mg arm.

Patients who had not previously underwent concomitant chemotherapy had a greater diminishment perceived cognitive impairment subscale score from baseline of 8.8 (95% CI, 4.9-12.6) compared with 4.5 (95% CI, 2.5-6.5) for those who had (P = .048).

AEs such as headache was the most common self-reported symptom in 41% (95% CI, 35%-47%; P = .28) of patients. In total, 47% (95% CI, 37%-57%) of patients in the 250 mg arm experienced headaches compared with 40% (95% CI, 31%-50%) in the 150 mg arm and 35% (95% CI, 26%-46%) in the placebo arm. The difference, however, was not statistically significant. Between the treatment arms, more patients reported insomnia in the 250 mg arm than the others.

References

1. Porter AB, Liu H, Kohli S, et al. Efficacy of treatment with armodafinil for cancer-related fatigue in patients with High-grade glioma: A phase 3 randomized clinical trial. JAMA Oncol. 2021;e215948. doi:10.1001/jamaoncol.2021.5948

2. Page BR, Shaw EG, Lu L, et al. Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue. Neuro-Oncol. 2015;17(10):1393-1401. doi:10.1093/neuonc/nov084

Recent Videos
“Dendritic cell vaccines, CAR T-cell therapy, and things of that nature are holding some promise,” said Andrew Brenner, MD, PhD.
Specialties including neurosurgery, radiation oncology, and neuro-rehabilitation all play a notable role in the care of patients with brain tumors.
Treatment-related toxicities during neuro-oncology therapy appear well managed with dose modifications and treatment cycle holds.
CAR T-cell therapies appear to be an evolving modality in the treatment of those with intracranial tumors, said Sylvia Kurz, MD, PhD.
Related Content
Advertisement

New ASTRO Guidelines Highlight RT in WHO Grade 4 Adult-Type Diffuse Glioma

New ASTRO Guidelines Highlight RT in WHO Grade 4 Adult-Type Diffuse Glioma

Ariana Pelosci
July 6th 2025
Article

Updated guidelines from ASTRO recommend various radiation therapy techniques for patients with WHO grade 4 adult-type diffuse glioma.


Shwetal Mehta, PhD, emphasizes her institution’s patient-focused and scientifically rigorous philosophy when developing new therapies in brain cancer.

Conducting Early Phase Trials of Promising Treatments in Neuro-Oncology

Shwetal Mehta, PhD
January 27th 2025
Podcast

Shwetal Mehta, PhD, emphasizes her institution’s patient-focused and scientifically rigorous philosophy when developing new therapies in brain cancer.


FDA Grants Fast-Track Designation to RAD101 Imaging for Brain Metastases

FDA Grants Fast-Track Designation to RAD101 Imaging for Brain Metastases

Tim Cortese
June 12th 2025
Article

The developer plans to share top-line results for RAD101 in various solid tumors from the supporting phase 2b trial in the second half of 2025.


The only way forward in the brain cancer field is to be open to mentoring others, according to Yoshie Umemura, MD.

Forming Connections and Making a Difference in the Brain Cancer Field

Yoshie Umemura, MD
October 7th 2024
Podcast

The only way forward in the brain cancer field is to be open to mentoring others, according to Yoshie Umemura, MD.


Rhenium Obisbemeda Improves Survival in Recurrent Glioblastoma

Rhenium Obisbemeda Improves Survival in Recurrent Glioblastoma

Ariana Pelosci
May 30th 2025
Article

Andrew Brenner, MD, PhD, discussed rhenium obisbemeda and results from the ReSPECT-GBM trial for patients with glioblastoma.


FDA Grants RMAT Designation to CAR T Therapy for Incurable Pediatric Glioma

FDA Grants RMAT Designation to CAR T Therapy for Incurable Pediatric Glioma

Tim Cortese
May 16th 2025
Article

The B7-H3 CAR T-cell therapy showed positive survival results for younger patients with diffuse intrinsic pontine glioma in a phase 1 trial.

Related Content
Advertisement

New ASTRO Guidelines Highlight RT in WHO Grade 4 Adult-Type Diffuse Glioma

New ASTRO Guidelines Highlight RT in WHO Grade 4 Adult-Type Diffuse Glioma

Ariana Pelosci
July 6th 2025
Article

Updated guidelines from ASTRO recommend various radiation therapy techniques for patients with WHO grade 4 adult-type diffuse glioma.


Shwetal Mehta, PhD, emphasizes her institution’s patient-focused and scientifically rigorous philosophy when developing new therapies in brain cancer.

Conducting Early Phase Trials of Promising Treatments in Neuro-Oncology

Shwetal Mehta, PhD
January 27th 2025
Podcast

Shwetal Mehta, PhD, emphasizes her institution’s patient-focused and scientifically rigorous philosophy when developing new therapies in brain cancer.


FDA Grants Fast-Track Designation to RAD101 Imaging for Brain Metastases

FDA Grants Fast-Track Designation to RAD101 Imaging for Brain Metastases

Tim Cortese
June 12th 2025
Article

The developer plans to share top-line results for RAD101 in various solid tumors from the supporting phase 2b trial in the second half of 2025.


The only way forward in the brain cancer field is to be open to mentoring others, according to Yoshie Umemura, MD.

Forming Connections and Making a Difference in the Brain Cancer Field

Yoshie Umemura, MD
October 7th 2024
Podcast

The only way forward in the brain cancer field is to be open to mentoring others, according to Yoshie Umemura, MD.


Rhenium Obisbemeda Improves Survival in Recurrent Glioblastoma

Rhenium Obisbemeda Improves Survival in Recurrent Glioblastoma

Ariana Pelosci
May 30th 2025
Article

Andrew Brenner, MD, PhD, discussed rhenium obisbemeda and results from the ReSPECT-GBM trial for patients with glioblastoma.


FDA Grants RMAT Designation to CAR T Therapy for Incurable Pediatric Glioma

FDA Grants RMAT Designation to CAR T Therapy for Incurable Pediatric Glioma

Tim Cortese
May 16th 2025
Article

The B7-H3 CAR T-cell therapy showed positive survival results for younger patients with diffuse intrinsic pontine glioma in a phase 1 trial.

Advertisement
About
Advertise
CureToday.com
OncLive.com
OncNursingNews.com
TargetedOnc.com
Editorial
Contact
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.