Clinical trial NCT03688633: Candesartan in Peripheral Neuropathy
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral Neuropathy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


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

Primary outcomes:
measure: TNSc score variation between V1 and V4
timeFrame: Between the base time (V1) and the end of chemotherapy (15 week later).
Secondary outcomes:
measure: TNSc score variation between V1 and V3
timeFrame: Between the base time (V1) and V3 (9 week later)
measure: Variation of visual analog scale (VAS)
timeFrame: Between the base time (V1) and 9 week and 15 week later
measure: Adverse effects
timeFrame: At baseline and each cycle up to 16 week
Other outcomes:
measure: Lipid peroxidation
timeFrame: through study completion, an average of 2 years
measure: Oxidative stres
timeFrame: through study completion, an average of 2 years
Locations:
city: Limoges
country: France
facility: CHU Limoges
Study officials:
References: