Candesartan in Peripheral Neuropathy

Phase 2

Terminated

• Conditions: Peripheral Neuropathy
• Interventions: Drug: Candesartan; Other: Usual care

• Registration Number: NCT03688633
• Lead Sponsor: University Hospital, Limoges

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2019-05-01
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Candesartan	Candesartan	-
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
TNSc score variation between V1 and V4	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

Secondary Outcome Measures

Name	Time	Method
Variation of visual analog scale (VAS)	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.
TNSc score variation between V1 and V3	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.
Adverse effects	At baseline and each cycle up to 16 week	any adverse/ side effect will be evaluated

Trial Locations

Locations (1)

CHU Limoges; 🇫🇷 Limoges, France