Clinical trial NCT02601547: PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma
Official title: PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Keywords: Positron-Emission Tomography
chemotherapy-induced brain damage
neuro-cognitive function alteration
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied.

Detailed description: Alteration of neuro-cognitive function induced by chemotherapy has been extensively documented in breast carcinoma patients. These modifications consist in the decrease of memory, intellectual capacity, speed analysis, and represent a real limitation for patients, sometimes durable. Aggressive lymphomas (diffuse large B cell lymphomas/DLBCL) represent a common disease, the standard being Rituximab-Cyclophosphamide-Doxorubicine-Vincristine-Prednisone (RCHOP) regiment which contains, as for breast cancer patients, anthracyclines. However, very little is known about the incidence and severity of cognitive function alteration in these patients. The occurrence of such complications should also be facilitated because of frail cognitive states due to age and co-morbidity. Cognitive function alteration is usually measured by neuropsychological tests (NPT) which are easy to handle and sensitive, but could lack specificity, in the context of general degradation which is often observed in hematological patients.

Positron emission tomography with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied. In our center, the investigators have already described glucidic hypometabolism in several brain territories associated with Alzheimer's disease and other dementia. Moreover, uptake quantification and topography are useful markers for determining the type of the disease and progression. PET-FDG received very little attention for the detection of chemotherapy-induced brain damages.

Eligibility criteria: Inclusion Criteria:

* histologically documented DLBCL
* previously untreated
* with International Prognostic Index (IPI) 0 or 1, or 2 without general state alteration (OMS≤2)
* submitted to RCHOP regimen (according to GELA's standard protocol)
* normal pre-treatment brain CT scan
* able to give informed consent
* speaking well French language
* benefiting from general medical insurance
* registered in the national listing of patients for biomedical research.

Exclusion Criteria:

* IPI \> or =3
* medical history of another cancer, or psychiatric or pre-dementia disorder, or convulsion
* barbituric regular use which can't be stop
* human immunodeficiency virus (HIV) patients
* unstable diabetes mellitus
* pregnancy

Primary outcomes:
measure: Change of Standard Uptake Value
timeFrame: 1 month after chemotherapy termination
measure: Change of Standard Uptake Value
timeFrame: 12 months after one year of achievement of chemotherapy
Secondary outcomes:
measure: change of functional learning test (WAIS)
timeFrame: 1 month after chemotherapy termination
measure: change of functional learning test (WAIS)
timeFrame: 12 months after one year of achievement of chemotherapy
measure: change of depression scale
timeFrame: 1 month after chemotherapy termination
measure: change of depression scale
timeFrame: 12 months after one year of achievement of chemotherapy
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anne Julian, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: