title: A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy.
abstract: Fatigue is common among glioma patients undergoing radiotherapy (RT) and impacts quality of life (QOL). We evaluated whether armodafinil, a wakefulness-promoting medication, improves fatigue in glioma patients undergoing RT.
  
  
  
  Eligibility criteria included age ≥18 years, Karnofsky performance status ≥60, and grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy. Patients were randomized 1:1 to armodafinil or placebo for 8 weeks beginning within 10 days of starting RT. Fatigue and QOL were assessed at baseline, day 22, day 43, and day 56 with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy - General (FACT-G), the Brief Fatigue Inventory (BFI), and the Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale between the 2 groups using a 2-sample Wilcoxon statistic.
  
  
  
  We enrolled 81 patients total (42 armodafinil and 39 placebo). Armodafinil did not significantly improve fatigue or QOL based on the 42-day change in FACIT-F fatigue subscale, FACT-G, CFS, or BFI. Further analysis suggests no difference between the arms even after accounting for the potential bias of missing data. Treatment was well tolerated with few grade 3 or 4 toxicities.
  
  
  
  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. Further studies are needed to determine whether pharmacologic treatment improves fatigue in glioma patients undergoing RT.
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Eudocia Q
authors.initials: EQ
authors.lastname: Lee
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Alona
authors.initials: A
authors.lastname: Muzikansky
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Jan
authors.initials: J
authors.lastname: Drappatz
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Santosh
authors.initials: S
authors.lastname: Kesari
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Eric T
authors.initials: ET
authors.lastname: Wong
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Camilo E
authors.initials: CE
authors.lastname: Fadul
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: David A
authors.initials: DA
authors.lastname: Reardon
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Norden
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Nayak
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Mikael L
authors.initials: ML
authors.lastname: Rinne
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Brian M
authors.initials: BM
authors.lastname: Alexander
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Nils D
authors.initials: ND
authors.lastname: Arvold
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Lisa
authors.initials: L
authors.lastname: Doherty
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Jennifer
authors.initials: J
authors.lastname: Stefanik
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Debra
authors.initials: D
authors.lastname: LaFrankie
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Sandra F
authors.initials: SF
authors.lastname: Ruland
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Julee
authors.initials: J
authors.lastname: Pulverenti
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Katrina H
authors.initials: KH
authors.lastname: Smith
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Gaffey
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Samantha
authors.initials: S
authors.lastname: Hammond
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005910:Glioma / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D010865:Pilot Projects; D011878:Radiotherapy / Q000009:adverse effects; D016896:Treatment Outcome; D064690:Wakefulness-Promoting Agents / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil
keywords: armodafinil; clinical trial; fatigue; glioblastoma; glioma