Peripheral NeuropathyPhase 1/2NCT05884281
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
A Phase 1/2 study testing Roflumilast in people with Peripheral Neuropathy, run by Mansoura University.
Trial summary
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Roflumilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2023
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
Who cannot join
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus or alcoholic disease.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
About this study
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
- Conditions
- Peripheral Neuropathy
- Being tested
- Roflumilast, Placebo
- 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.
RoflumilastDrug
0.5 mg once daily for treatment period
PlaceboDrug
Placebo for treatment period
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Drug: Roflumilast |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Number of patients reported neuropathy from paclitaxel
Measured: 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884281
- Sponsor's protocol ID
- 8/2023
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05884281
- Acronym / sponsor ID
- 8/2023
- Conditions
- Peripheral Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Roflumilast |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
Key exclusion criteria (3 listed)
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus or alcoholic disease.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
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 |
|---|---|---|
| Roflumilast0.5 mg once daily for treatment period | Drug | Intervention |
| PlaceboPlacebo for treatment period | Drug | Control |
Primary outcome
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time frame: 8 weeks post intervention
Number of patients reported neuropathy from paclitaxel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Roflumilast in people with Peripheral Neuropathy, run by Mansoura University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria (time frame: 8 weeks post intervention). 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 1 Jun 2023.