Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University

Criteria

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.