Candesartan in Peripheral Neuropathy (NCT03688633) | Clinical Trial Compass
TerminatedPhase 2
Candesartan in Peripheral Neuropathy
Stopped: Patient Recruitment Failure
France9 participantsStarted 2019-05-01
Plain-language 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)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TNSc score variation between V1 and V4
Timeframe: Between the base time (V1) and the end of chemotherapy (15 week later).