Evidence map›Paper›PMID 32642669›Full record

ArticleNeuro-oncology advances

A phase III double-blind placebo-controlled randomized study of dexamphetamine sulfate for fatigue in primary brain tumors patients: An ANOCEF trial (DXA).

Florence Laigle-Donadey, François Ducray, Matthieu Boone, Mamadou Hassimiou Diallo, David Hajage, Carole Ramirez, Olivier Chinot, Damien Ricard, Jean-Yves Delattre

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 6 pooled it
0.9field-weighted citation impact, top 22% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Florence Laigle-DonadeyAP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, Paris, France.ORCID 0000-0001-9907-703X
François DucrayHospices Civils de Lyon, Groupe Hospitalier Est, Service de Neuro-Oncologie, Lyon, Cedex, France.
Matthieu BooneService d'Oncologie Médicale, CHU Amiens-Picardie, Chimère, France.
Mamadou Hassimiou DialloSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière Charles Foix, Unité de Recherche Clinique, Paris, France.
David HajageSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Paris, France.
Carole RamirezService de Neurochirurgie, Hôpital Roger Salengro, CHRU de Lille, rue Emile Laine, Cedex, France.
Olivier ChinotAix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France.
Damien RicardHôpital d'Instruction des Armées Percy, Service de Santé des Armées, Clamart, France.
Jean-Yves DelattreAP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin; Sorbonne Université, UPMC Univ Paris 06, UMR S 1127; INSERM, U 1127; CNRS, UMR 7225; ICM, Paris, France.
Centre National de la Recherche Scientifique · FRInserm · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire de Lille · FRUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost 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.

methodsA 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.

resultsFrom 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 (

conclusionDexamphetamine 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.

Indexed as

dexamphetaminefatigueprimary brain tumors

Identifiers

PMID32642669
PMCPMC7212857
OpenAlexW2988909389

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.