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
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

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