Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia

Glioma Clinical Trial

— DXA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363075
• Other study ID #: P110501
• Status: Recruiting
• Phase: Phase 3
• First received: February 9, 2015
• Last updated: September 14, 2016
• Start date: April 2013
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florence LAIGLE-DONADEY, MD
• Email: florence.laigle-donadey[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthenia
• Glioma

Intervention

Drug:
• Dexamfetamine sulphate
10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
• placebo
10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No