Candesartan in Peripheral Neuropathy

NCT03688633 | Terminated Phase 2

• 1 other identifier: I16016 /NEUPERSART
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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)

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• TNSc score variation between V1 and V3

  Between the base time (V1) and V3 (9 week later)

• Variation of visual analog scale (VAS)

  Between the base time (V1) and 9 week and 15 week later

• Adverse effects

  At baseline and each cycle up to 16 week

Other Outcomes (2)

• Lipid peroxidation

  through study completion, an average of 2 years

• Oxidative stres

  through study completion, an average of 2 years

Study Arms (2)

Candesartan

EXPERIMENTAL

Drug: Candesartan

Usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Candesartan DRUG

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

Candesartan

Usual care OTHER

patients will be followed as usual

Usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Combined hormonal contraceptive (containing estrogen and progesterone) (oral, intravaginal, or transdermal) or only progesterone (oral, injectable or implantable),

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

candesartan

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: September 28, 2018
• Study Start: May 1, 2019
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)