Candesartan Preventive Traitement of Peripherical Neuropathy

Peripheral Neuropathy Clinical Trial

— NEUPERSART  

Official title:

Evaluation of the Contribution of Candesartan in the Prevention of Vincristine-induced Peripheral Neuropathies (VINP) in Patients Treated for B-cell Lymphoma. Randomized Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03805867
• Other study ID #: I16016/NEUPERSART
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2018
• Source: University Hospital, Limoges
• Contact: Laurent MAGY, MD
• Phone: 05 55 05 65 68
• Email: laurent.magy[@]unilim.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study can describe in patients treated for non-Hodgkin's type B malignant lymphoma with multidrug therapy containing Vincristine, the impact of Candesartan on the occurrence of neuropathy measured by variation in TNSc (Total Neuropathy Score clinical version, evaluating clinical signs neuropathy) between basal time (V1) and the end of chemotherapy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient aged 18 to 80

• Patient with non-Hodgkin's malignant lymphoma (NHL) B to be treated with multidrug therapy containing vincristine (primary treatment) [R-CHOP with 1.3 mg / m2 vincristine up to 2 mg total dose].

• Creatinine clearance MDRD> 30 mmol / min / 1.73 m2

• Kaliemia <5.5 mmol / l

• NOT more than 100 mm Hg lying and standing

• Patient accepting the constraints of the protocol (in particular 2 skin biopsies)

• Patient affiliated or beneficiary of a social security scheme

• For women of childbearing potential: "highly effective" contraception and negative pregnancy test at baseline. Highly effective contraception

Exclusion Criteria:

• Patients who have already been treated with vincristine for B-cell lymphoma

• Patient with a potential cause of previously known neuropathy (such as diabetes, chronic alcoholism, prior vitamin deficiency known, HIV infection ...).

• Patients under guardianship or curatorship or otherwise unable to give informed consent.

• CI sartans: severe hepatic insufficiency, cholestasis, hypersensitivity to candesartan, association candesartan + drugs containing aliskiren in patients with diabetes or renal impairment (GFR [Glomerular Filtration Rate] <60 ml / min / 1, 73 m2)

• Intolerance to the excipients of the specialty used in the study.

• Patients taking an ACE inhibitor, sartan or any hyperkalaemic treatment

• Contraindication to cutaneous biopsy: allergy to local anesthetics (lidocaine) or patient on anticoagulant or known blood crease disorder

• Pregnant or lactating women according to article L1121-5 of the CSP

• Vulnerable people according to article L1121-6 of the CSP

• Majors subject to a legal protection measure or to express their consent according to article L1121-8 of the CSP

• Have participated in another therapeutic trial up to 60 days before this trial.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Procedure:
• survey
usual care alone (no treatment with Candésartan) Their first chemotherapy containing Vincristine (according to the good practice habits of the Clinical Hematology and Cell Therapy department) will then be administered

Drug:
• Candesartan
Candesartan (8mg) will be prescribed and delivered for a first dose the same day, in addition to the usual care. A prescription is given to the patient (experimental group) for measurement of serum creatinine and serum potassium at home after 7 days of treatment (D8).

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation V1-V4 of TNSc score (clinical signs of neuropathy, total neuropathy score clinical version)	The evaluation of the TNSc will be performed by a blinded evaluator of the randomization group.This score is validated in neuropathies induced by chemotherapy (Cavaletti et al., 2007).	15 weeks