Glioma Clinical Trial
Official title:
A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial
The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.
Quality of life of patients with stabilized gliomas is often impacted by a severe physical
and psychological fatigue resulting from both tumor and side effects of treatments.
It is a randomized double blind Placebo-Controlled Trial evaluating the effect of
dexamfetamine sulphate on severe fatigue in glioma patients. Half of the participants will
receive dexamfetamine sulphate and the other half will receive a placebo. Neither the
participant nor the study doctor will know what group they are in.
The main objective is to assess the impact at 3 months of dexamfetamine sulphate in patients
suffering from a RANO stable or responsive glioma complaining of a severe fatigue
(quantified by the Multidimensional Fatigue inventory - MFI 20 scale).
The secondary objectives include: evaluation of side effects, quality of life, cognitive
functions, depression, variation in time of both fatigue scales MFI 20 and VAS.
58 patients will be included. In patients complaining of severe asthenia, with a non
progressive neuro-oncological disease, and without criteria of depression revealed by HAD
(Hospital Anxiety and Depression) scale, evaluation of fatigue will be done with the MFI 20
scale. Patients with a MFI 20 score ≥60/100 and corresponding to inclusion criteria will be
invited to participate.
After randomisation, a baseline evaluation will be done, including MFI20, Norris VAS, EORTC
QLQ-C30, Mattis scale, Trail Making Test, Grober and Buschke, Wisconsin Card Sorting Test ,
HAD scale and Marin scale.
Patients will receive, in a double blinded way, six pills a day either of dexamphetamine
sulfate (15 mg*2) or of placebo, during 3 months, after an initial phase of progressive
increasing levels of dose every 10 days, depending on tolerance.
The evaluation of fatigue, quality of life will be done every month during the 3 months of
treatment. The cognitive evaluation will be done at 3 months.
The main criteria of evaluation is the variation during 3 months of the MFI 20 score in non
progressive patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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