Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
- Registration Number
- NCT05884281
- Lead Sponsor
- Mansoura University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo - Intervention Roflumilast -
- Primary Outcome Measures
Name Time Method Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria 8 weeks post intervention Number of patients reported neuropathy from paclitaxel
- Secondary Outcome Measures
Name Time Method