Peripheral NeuropathyPhase 2NEUPERSARTNCT03688633
Candesartan in Peripheral Neuropathy
A Phase 2 study testing Candesartan in people with Peripheral Neuropathy, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Candesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 27 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B
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.
Read more
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
- Being tested
- Candesartan, Usual care
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects
Usual careOther
patients will be followed as usual
| Study group | Role | What they receive |
|---|---|---|
| Candesartan | Experimental | Not described Receives: Drug: Candesartan |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between the base time (V1) and the end of chemotherapy (15 week later).
Secondary outcomes (3)
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.
Measured: 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.
Measured: Between the base time (V1) and 9 week and 15 week later
Adverse effects
any adverse/ side effect will be evaluated
Measured: At baseline and each cycle up to 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 May 2019
- Primary completion27 May 2021
- Study completion27 May 2021
Why it stopped: Patient Recruitment Failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688633
- Sponsor's protocol ID
- I16016 /NEUPERSART
- Acronym
- NEUPERSART
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2018
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B
- ClinicalTrials.gov ID
- NCT03688633
- Acronym / sponsor ID
- NEUPERSART / I16016 /NEUPERSART
- Conditions
- Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient Recruitment Failure
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan | Experimental | Drug: Candesartan |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CandesartanCandesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects | Drug | Candesartan |
| Usual carepatients will be followed as usual | Other | Usual care |
Primary outcome
TNSc score variation between V1 and V4
Time frame: 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
3 secondary outcomes
TNSc score variation between V1 and V3
Time frame: Between the base time (V1) and V3 (9 week later)
Variation of visual analog scale (VAS)
Time frame: Between the base time (V1) and 9 week and 15 week later
Adverse effects
Time frame: At baseline and each cycle up to 16 week
Results and safety
The study was stopped early (reason given: Patient Recruitment Failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candesartan in people with Peripheral Neuropathy, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient Recruitment Failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNSc score variation between V1 and V4 (time frame: Between the base time (V1) and the end of chemotherapy (15 week later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.