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NCT05884281 Clinical Trial

Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05884281
Other study ID # 8/2023
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 2023
Est. completion date December 2023

Study information
Verified date May 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Breast cancer patients who will receive paclitaxel post-anthracycline therapy. 2. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. 3. 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). Exclusion Criteria: 1. Patients with signs and symptoms of clinical neuropathy at baseline. 2. Patients with diabetes mellitus or alcoholic disease. 3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Roflumilast
0.5 mg once daily for treatment period
• Placebo
Placebo for treatment period

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 8 weeks post intervention
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