Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia

Phase 3

• Conditions: Glioma
• Interventions: Drug: Dexamfetamine sulphate; Drug: placebo

• Registration Number: NCT02363075
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Status Verified: 2016-08
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15
• Primary Completion: 2017-07
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamfetamine sulphate	Dexamfetamine sulphate	Dexamfetamine Sulphate 5 mg Tablets
placebo	placebo	Aspect tablets identical to the active

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue inventory - MFI 20 scale score	3 months	improvement of the MFI 20 score between the inclusion and the evaluation at 3 months in case of non progressive disease during this period of time.

Trial Locations

Locations (1)

Groupe Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France