DXA: Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02363075

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Drug: Dexamfetamine sulphate Drug: placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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