peripheral neuropathy MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10029331 Term: Neuropathy peripheral System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: CANDESARTAN
Product Name: CANDESARTAN
Pharmaceutical Form: Tablet
INN or Proposed INN: CANDESARTAN CILEXETIL
Other descriptive name: CANDESARTAN CILEXETIL
Concentration unit: mg milligram
Sponsors
CHU de Limoges
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 years and over and to be treated with Vincristine for non-Hodgkin B lymphoma (first line treatment) - All the patients have to be treated with the same chemotherapy protocol (CHOP with or without Rituximab) to avoid confounding factors - Normal renal function as measured by MDRD > 30 mmol / min / 1.73 m2 - Serum potassium 100 mm Hg (lying and standing position) - affiliated with a social security - For women of childbearing age: under "highly effective" contraception and negative pregnancy test at inclusion. Highly effective contraception: *Combined hormonal contraceptive (containing estrogen and progesterone) (oral, intravaginal, or transdermal) or only progesterone (oral, injectable or implantable), *intrauterine device, *Tubal occlusion, bilateral *vasectomized partner, *sexual abstinence. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patients with pre-existing neuropathy, diabetic patients, Chronic ethylism, known previous vitamin deficiency, HIV infection, etc. - Patients under guardianship or unable for another reason to give informed consent. - CI to sartans - Intolerance to excipients : galactose , lactose. - Patients already treated with ACE inhibitors, ARBs or/and diuretics sparing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the clinical study is: Describing the impact of Candesartan on the occurrence of neuropathy as measured by variation in Total Clinical Neuropathy Score (TNSc) in patients treated for non-Hodgkin's lymphoma type B with multidrugine-containing chemotherapy, evaluating clinical signs Of neuropathy) between baseline (V1) and end of chemotherapy (V4). ;Secondary Objective: *Describe the variation of TNSc between V1 and V3 (V1 + 9 weeks +/- 5 days) and the variation between V1 and V3, between V1 and V4 in patients treated for non-Hodgkin's lymphoma type B with polycimiotherapy containing Vincristine in 2 groups ( I) patients with administration of candesartan and (ii) patients with usual management *pain assessed by EVA *the amplitude of the motor potentials (total motor action potential (PGAM)) for the fibular, deep and ulnar nerves unilaterally (non-dominant side) *the amplitude of sensory potentials measured for the sural and radial nerves unilaterally (non-dominant side). *Cutaneous electroconductance (expressed in microsiemens or us) of the palms of the hands and plants of the feet. *Study of serum biomarkers with V1, V3, V4 and cutaneous V1, V3 during the development of a neuropathy induced by Vincristine in 2 groups(i,ii) *Determine the safety profile of Candesartan in 2 groups (i,ii);Primary end point(s): presence and severity of the peripheral neuropathy, as measured by the TNSc (Total Neuropathy Score) validated in CIPN ;Timepoint(s) of evaluation of this end point: Between the base time (V1) and the end of chemotherapy (V4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in visual analogic scale -Electrochemical conductance of hands and feet (expressed in microsiemens) as measured by Sudoscan -Change in amplitudes of motor and sensory nerve action potentials -Biological markers ;Timepoint(s) of evaluation of this end point: Between V1 and V3 and between V1 and V4 | — |
Countries
France
Contacts
Public ContactProject Manager
CHU de Limoges
Outcome results
None listed