Trial reportNeuro-oncology2015
Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue.
Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph
Trial report in Neuro-oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 9 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 9 pooled it
7.2field-weighted citation impact, top 2% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 9 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Guideline
- A systematic review of cognitive interventions for adult patients with brain tumours.Cancer medicine · 2023Pooled it
- Interventions for preventing and ameliorating cognitive deficits in adults treated with cranial irradiation.The Cochrane database of systematic reviews · 2022Pooled it
- Interventions for the management of fatigue in adults with a primary brain tumour.The Cochrane database of systematic reviews · 2022Pooled it
- Pharmacologic interventions for fatigue in cancer and transplantation: a meta-analysis.Current oncology (Toronto, Ont.) · 2018Pooled it
- Interventions for the management of fatigue in adults with a primary brain tumour.The Cochrane database of systematic reviews · 2016Pooled it
- Pharmacological treatments for fatigue associated with palliative care.The Cochrane database of systematic reviews · 2015Pooled it
- Interventions for preventing and ameliorating cognitive deficits in adults treated with cranial irradiation.The Cochrane database of systematic reviews · 2014Pooled it
- Pharmacological Interventions for the Management of Cancer-Related Fatigue Among Cancer Survivors: Systematic Review and Meta-Analysis.Integrative cancer therapiesPooled it
- Bayesian adaptive randomized trial of blended cognitive behavioral therapy for severe fatigue in stable diffuse glioma.Neuro-oncology · 2026Trial
- Effects of low-dose naltrexone on quality of life in high-grade glioma patients: a placebo-controlled, double-blind randomized trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Trial
- A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy.Neuro-oncology · 2016Trial
- Mapping the global research landscape and innovations on elderly glioma: a bibliometric analysis.Frontiers in oncology · 2026Article
- Glioblastoma in adults: A Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.Neuro-oncology · 2025Review
- Symptom management in isocitrate dehydrogenase mutant glioma.Neuro-oncology practice · 2025Review
- Low-Grade Glioma Clinical Trials in the United States: A Systematic Review.Life (Basel, Switzerland) · 2024Review
- Armodafinil as a Potential Pharmacological Treatment for Attention Deficit Hyperactivity Disorder in Adults: A Review.Current neuropharmacology · 2024Review
- Recognition and Management of the Long-term Effects of Cranial Radiation.Current treatment options in oncology · 2023Review
- Lifestyle coaching is feasible in fatigued brain tumor patients: A phase I/feasibility, multi-center, mixed-methods randomized controlled trial.Neuro-oncology practice · 2023Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Brandi R PageDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Edward G ShawDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Lingyi LuDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
David BryantDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
David GrisellDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Glenn J LesserDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Drew C MonittoDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Michelle J NaughtonDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Stephen R RappDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Steven R SavonaDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Sunjay ShahDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Doug CaseDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Michael D ChanDepartment of Radiation Oncology, Medical Center Blvd, Wake Forest School of Medicine, Winston-Salem, North Carolina (B.R.P., E.G.S., M.D.C.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina (L.L., D.C.); Department of Medical Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina (G.J.L.); Via Christi Cancer Center, Witchita, Kansas (D.B.); Greenville Health System Cancer Institute, Greenville, South Carolina (D.G.); Spartanburg Regional Healthcare System, Spartanburg, South Carolina (D.C.M.); Hofstra Northshore-LIJ School of Medicine, New Hyde Park, New York (S.R.S.); Christiana Care CCOP, Newark, Delaware (S.S.); Wake Forest University Department of Geriatric Medicine, Memory Assessment Clinic Counseling Center, Winston-Salem, North Carolina (E.G.S.); Department of Medicine, Ohio State University, Columbus, Ohio (M.J.N.); Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, North Carolina (S.R.R.).
Wake Forest University · US
Funding
Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9MTumor Tissue CoreP30CA012197 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Ruben A. Mesa · 1985 to 2026
$55.4MNorthwell Health NCORPUG1CA189850 · NCI · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI VINCENT P VINCIGUERRA · 2014 to 2026
$13.3MNCI NIH HHS P30 CA012197NCI NIH HHS UG1 CA189824NCI NIH HHS UG1 CA189850
Abstract
backgroundCommon acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT.
methodsA phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect.
resultsFrom September 20, 2010, to October 20, 2012, 54 participants enrolled with 80% retention and 94% self-reported compliance. There were no grade 4-5 toxicities, and the incidence of grade 2-3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15%), headaches (19%), and insomnia (20%). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes.
conclusionArmodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue.
Indexed as
AdultAgedBenzhydryl CompoundsBrain NeoplasmsDouble-Blind MethodFatigueFemaleGlioblastomaHumansMaleMeningiomaMiddle AgedModafinilQuality of LifeRadiotherapyTreatment OutcomeBenzhydryl CompoundsModafinilWakefulness-Promoting Agentsarmodafinilcognitive functionfatigueprimary brain tumorsradiotherapy
Identifiers
What OpenQuestion holds
Textmetadata
Read underepoch 390
Registered trials
None linked
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.