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Candesartan in Peripheral Neuropathy (NEUPERSART)

Primary Purpose

Peripheral Neuropathy

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Candesartan
Usual care
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Candesartan

Usual care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Adverse effects
any adverse/ side effect will be evaluated

Full Information

First Posted
September 8, 2018
Last Updated
November 12, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03688633
Brief Title
Candesartan in Peripheral Neuropathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Patient Recruitment Failure
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candesartan
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Candesartan
Intervention Description
Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
patients will be followed as usual
Primary Outcome Measure Information:
Title
TNSc score variation between V1 and V4
Description
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
Time Frame
Between the base time (V1) and the end of chemotherapy (15 week later).
Secondary Outcome Measure Information:
Title
TNSc score variation between V1 and V3
Description
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.
Time Frame
Between the base time (V1) and V3 (9 week later)
Title
Variation of visual analog scale (VAS)
Description
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.
Time Frame
Between the base time (V1) and 9 week and 15 week later
Title
Adverse effects
Description
any adverse/ side effect will be evaluated
Time Frame
At baseline and each cycle up to 16 week
Other Pre-specified Outcome Measures:
Title
Lipid peroxidation
Description
Theses markers of vincristine-induced axonal involvement Lipid peroxidation will be assessed by measurement of MDA malondialdehyde (TBARS) and 8-Isoprostane
Time Frame
through study completion, an average of 2 years
Title
Oxidative stres
Description
Oxidative stress will be evaluated by measuring the activities of superoxide dismutase (SOD) and glutathione peroxidase (GHS-PX).
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Candesartan in Peripheral Neuropathy

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