Clinical Trials Logo

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.


Clinical Trial 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

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


NCT number NCT02363075
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Florence LAIGLE-DONADEY, MD
Email florence.laigle-donadey@psl.aphp.fr
Status Recruiting
Phase Phase 3
Start date April 2013
Completion date January 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2