Candesartan in Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

— NEUPERSART  

Official title:

Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03688633
• Other study ID #: I16016 /NEUPERSART
• Status: Terminated
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: May 27, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

Chemotherapy induced peripheral neuropathy (CIPN) is often painful, and is caused by neurotoxic chemotherapy including vincristine. It is a cause of significant impairment in quality of life in patients surviving to a solid cancer or malignant lymphoma. The only recognized prevention is based on pre-existing neuropathy and early detection of neuropathic signs and symptoms in individuals subjected to neurotoxic chemotherapy, justifying sometimes a change in the therapeutic strategy when other molecules are available. It seems obvious that to identify early markers of CIPN and to develop preventive therapeutic strategies, are priorities for improving patients' quality of life and enable them to follow optimal treatment.

Purpose:

To 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 the variation of TNSc (Total Neuropathy Score clinical version, evaluating clinical signs of neuropathy)

Other known NCT identifiers

• NCT03805867

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 CKD-EPI > 30 mmol / min / 1.73 m2

• Serum potassium < 5.5 mmol / l

• Systolic arterial pressure > 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),

Exclusion Criteria:

• Patients with pre-existing neuropathy, Chronic ethylism, HIV infection, etc.

• Patients under guardianship or unable for another reason to give informed consent.

• Intolerance to sartans

• Intolerance to excipients : galactose , lactose.

• Patients already treated with ACE inhibitors, ARBs or/and diuretics sparing

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Candesartan
Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects

Other:
• Usual care
patients will be followed as usual

Locations

Country	Name	City	State
France	CHU 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
Other	Lipid peroxidation	Theses markers of vincristine-induced axonal involvement Lipid peroxidation will be assessed by measurement of MDA malondialdehyde (TBARS) and 8-Isoprostane	through study completion, an average of 2 years
Other	Oxidative stres	Oxidative stress will be evaluated by measuring the activities of superoxide dismutase (SOD) and glutathione peroxidase (GHS-PX).	through study completion, an average of 2 years
Primary	TNSc score variation between V1 and V4	The primary endpoint in this clinical study is the V1 - V4 variation of the TNSc score TNSc is the Total Neuropathy Score Clinical version scale; Validated 7-item TNSc quantifies subjective sensory and motor symptoms, vibration sensation, strength, and reflexes.Items are rated using a 0 to 4 scale and summed to obtain a total score ranging from 0 to 28. Higher scores reflect more severe neuropathy.; The evaluation of the TNSc will be performed by a blinded evaluator of the randomization group	Between the base time (V1) and the end of chemotherapy (15 week later).
Secondary	TNSc score variation between V1 and V3	VariationVariation between V1 and V3 of the TNSc score. TNSc is the Total Neuropathy Score Clinical version scale; Validated 7-item TNSc quantifies subjective sensory and motor symptoms, vibration sensation, strength, and reflexes.Items are rated using a 0 to 4 scale and summed to obtain a total score ranging from 0 to 28. Higher scores reflect more severe neuropathy.; The evaluation of the TNSc will be performed by a blinded evaluator of the randomization group.	Between the base time (V1) and V3 (9 week later)
Secondary	Variation of visual analog scale (VAS)	Variation oh the VAS score between V1 - V3 and between V1- V4 The visual analogue scale (VAS) is commonly used as the outcome measure to characterize the intensity of pain . It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."; Higher scores reflect more severe pain.	Between the base time (V1) and 9 week and 15 week later
Secondary	Adverse effects	any adverse/ side effect will be evaluated	At baseline and each cycle up to 16 week