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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02363075
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : February 13, 2015
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : January 2018


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.




Primary Outcome Measures :
  1. Multidimensional Fatigue inventory - MFI 20 scale score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363075


Contacts
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Contact: Florence LAIGLE-DONADEY, MD florence.laigle-donadey@psl.aphp.fr

Locations
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France
Groupe Hospitalier Pitie Salpetriere Recruiting
Paris, France, 75013
Contact: Florence LAIGLE-DONADEY, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Florence LAIGLE-DONADEY, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02363075    
Other Study ID Numbers: P110501
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: August 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
dexamfetamine sulphate
severe asthenia
glioma
MFI-20
double-blind
stabilisation phase
Additional relevant MeSH terms:
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Glioma
Asthenia
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Signs and Symptoms
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents