- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688633
Candesartan in Peripheral Neuropathy (NEUPERSART)
Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87042
- CHU Limoges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
patients will be followed as usual
|
Experimental: Candesartan
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Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TNSc score variation between V1 and V4
Time Frame: Between the base time (V1) and the end of chemotherapy (15 week later).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TNSc score variation between V1 and V3
Time Frame: Between the base time (V1) and V3 (9 week later)
|
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)
|
Variation of visual analog scale (VAS)
Time Frame: Between the base time (V1) and 9 week and 15 week later
|
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
|
Adverse effects
Time Frame: At baseline and each cycle up to 16 week
|
any adverse/ side effect will be evaluated
|
At baseline and each cycle up to 16 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid peroxidation
Time Frame: through study completion, an average of 2 years
|
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
|
Oxidative stres
Time Frame: through study completion, an average of 2 years
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I16016 /NEUPERSART
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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