Not provided
Not provided
Not provided
Patient Recruitment Failure
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan | Experimental |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan | Drug | Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid peroxidation | 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 |
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Limoges | Limoges | 87042 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C081643 | candesartan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care | Other | patients will be followed as usual |
|
| Between the base time (V1) and V3 (9 week later) |
| 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. | Between the base time (V1) and 9 week and 15 week later |
| Adverse effects | any adverse/ side effect will be evaluated | At baseline and each cycle up to 16 week |
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 |