Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Mansoura University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Peripheral Neuropathy

Interventions

RoflumilastDRUG

0.5 mg once daily for treatment period

PlaceboDRUG

Placebo for treatment period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 8 weeks post intervention

Data from ClinicalTrials.gov

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