A phase III double-blind placebo-controlled randomized study of dexamphetamine sulfate for fatigue in primary brain tumors patients: An ANOCEF trial (DXA).
dexamphetamine
fatigue
primary brain tumors
Journal
Neuro-oncology advances
ISSN: 2632-2498
Titre abrégé: Neurooncol Adv
Pays: England
ID NLM: 101755003
Informations de publication
Date de publication:
Historique:
entrez:
10
7
2020
pubmed:
10
7
2020
medline:
10
7
2020
Statut:
epublish
Résumé
Most patients suffering from a primary brain tumor (PBT) complain of chronic fatigue affecting their quality of life (QOL). We hypothesized that dexamphetamine sulfate, a psychostimulant drug, could improve fatigue in PBT patients. A double-blind, phase III, multi-institutional, placebo-controlled randomized trial (1:1 allocation) assessed the efficacy and tolerability of dexamphetamine at a dosage of 30 mg/day in PBT patients with stable disease who complained of severe fatigue, defined as a Multidimensional Fatigue Inventory (MFI-20) score ≥60. The primary outcome was the variation of the MFI 20 score between inclusion and the evaluation at 3 months in nonprogressive patients. Mood, QOL and cognitive function were also evaluated. From April 2013 to November 2016, 46 patients were enrolled in the study, 41 of whom were evaluable for analysis (dexamphetamine group: 22; placebo group: 19). Tolerance was generally good, with no treatment-related deaths and no grade 4 toxicity. Patients in the dexamphetamine arm complained more frequently of psychiatric side effects (mostly hyperactivity, anxiety, sleep disorder, and irritability) than patients in the placebo arm ( Dexamphetamine at a dosage of up to 30 mg/day for 3 months has acceptable tolerability in PBT patients but does not improve fatigue, cognitive function, or QOL.
Sections du résumé
BACKGROUND
BACKGROUND
Most patients suffering from a primary brain tumor (PBT) complain of chronic fatigue affecting their quality of life (QOL). We hypothesized that dexamphetamine sulfate, a psychostimulant drug, could improve fatigue in PBT patients.
METHODS
METHODS
A double-blind, phase III, multi-institutional, placebo-controlled randomized trial (1:1 allocation) assessed the efficacy and tolerability of dexamphetamine at a dosage of 30 mg/day in PBT patients with stable disease who complained of severe fatigue, defined as a Multidimensional Fatigue Inventory (MFI-20) score ≥60. The primary outcome was the variation of the MFI 20 score between inclusion and the evaluation at 3 months in nonprogressive patients. Mood, QOL and cognitive function were also evaluated.
RESULTS
RESULTS
From April 2013 to November 2016, 46 patients were enrolled in the study, 41 of whom were evaluable for analysis (dexamphetamine group: 22; placebo group: 19). Tolerance was generally good, with no treatment-related deaths and no grade 4 toxicity. Patients in the dexamphetamine arm complained more frequently of psychiatric side effects (mostly hyperactivity, anxiety, sleep disorder, and irritability) than patients in the placebo arm (
CONCLUSION
CONCLUSIONS
Dexamphetamine at a dosage of up to 30 mg/day for 3 months has acceptable tolerability in PBT patients but does not improve fatigue, cognitive function, or QOL.
Identifiants
pubmed: 32642669
doi: 10.1093/noajnl/vdz043
pii: vdz043
pmc: PMC7212857
doi:
Types de publication
Journal Article
Langues
eng
Pagination
vdz043Informations de copyright
© The Author(s) 2019. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
Références
Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1496-501
pubmed: 17869448
Ned Tijdschr Geneeskd. 2005 Jun 4;149(23):1283-8
pubmed: 15960135
Neuro Oncol. 2016 Jun;18(6):759-60
pubmed: 27044296
Psychosomatics. 2003 Jan-Feb;44(1):38-43
pubmed: 12515836
Neuro Oncol. 2016 Jun;18(6):849-54
pubmed: 26902850
Neuro Oncol. 2016 Feb;18(2):252-60
pubmed: 26289592
Psychiatry Res. 2001 Nov 30;104(3):247-57
pubmed: 11728614
J Clin Oncol. 1998 Jul;16(7):2522-7
pubmed: 9667273
J Nurs Scholarsh. 2007;39(1):61-7
pubmed: 17393967
J Clin Psychiatry. 2000 Jun;61(6):436-40
pubmed: 10901342
Support Care Cancer. 2000 Sep;8(5):385-97
pubmed: 10975688
Pediatrics. 1999 Apr;103(4):e43
pubmed: 10103335
JAMA Oncol. 2017 Jul 1;3(7):961-968
pubmed: 28253393
Cochrane Database Syst Rev. 2016 Apr 13;4:CD011376
pubmed: 27074263
J Natl Compr Canc Netw. 2010 Aug;8(8):933-42
pubmed: 20870637
Am J Hosp Palliat Care. 2001 May-Jun;18(3):187-92
pubmed: 11406895
Neuro Oncol. 2000 Oct;2(4):221-8
pubmed: 11265231
J Neurooncol. 2006 Feb;76(3):283-91
pubmed: 16163448
Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64
pubmed: 12641557
Neuro Oncol. 2015 Oct;17(10):1393-401
pubmed: 25972454
J Pain Symptom Manage. 2009 Apr;37(4):613-21
pubmed: 18790598
Neuro Oncol. 2013 Oct;15(10):1420-8
pubmed: 23925452
J Clin Oncol. 2015 May 20;33(15):1653-9
pubmed: 25897156