Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia (DXA)

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.

Study Overview

• Status: Unknown
• Conditions: Glioma
• Intervention / Treatment: Drug: Dexamfetamine sulphate; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Florence LAIGLE-DONADEY, MD; Email: florence.laigle-donadey@psl.aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Groupe Hospitalier Pitie Salpetriere
    • Contact: Florence Laigle-Donadey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Patients complaining of a severe asthenia defined as a MFI 20 score ≥ 60/100
• Patients suffering from histologically proven gliomas
• Patients with responsive or stable disease (according to RANO criteria) for at least 3 months, either still on chemotherapy or only being under simple surveillance
• stable dosage of steroids for at least 1 week
• Time elapsed post-radiotherapy more than 3 months
• HAD score of depression ≤8
• Karnofsky performance index ≥ 60
• ≥ 18 years of age
• contraceptive measures
• written informed consent
• Depending from the french system of health assurance

Exclusion criteria :

• Severe aphasia or other symptoms compromising the tests execution
• concomitant uncontrolled pathology
• Known symptomatic or constitutional cardiovascular disease, (cardiac arrhythmia, recent myocardial infarction, chest pain, history of unstable angina) and/or uncontrolled hypertension, (≥ 16/10), arteriosclerosis, cardiac abnormality detected at the initial cardiac echography.
• Hyperthyroidism
• Known hypersensitivity to dexamphetamine or related compounds
• Glaucoma
• Porphyria
• Hemoglobin level of less than 10,0 g/dL
• Alcohol or drug abuse,
• Agitation
• Tourette's syndrome
• Patients who have been receiving MAO inhibitors during the past 14 days
• Hereditary hypersensitivity to galactose, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
• Hereditary hypersensitivity to saccharose, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency
• Pregnant or lactating woman
• Non french speaker
• History of psychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamfetamine sulphate; Dexamfetamine Sulphate 5 mg Tablets	Drug: Dexamfetamine sulphate; 10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
Placebo Comparator: placebo; Aspect tablets identical to the active	Drug: placebo; 10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Fatigue inventory - MFI 20 scale score	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.	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Florence LAIGLE-DONADEY, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: glioma; double-blind; dexamfetamine sulphate; severe asthenia; MFI-20; stabilisation phase
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Asthenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Dextroamphetamine
• Other Study ID Numbers: P110501