Peripheral Neuropathy
Conditions
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.
Interventions
DRUGRoflumilast
0.5 mg once daily for treatment period
DRUGPlacebo
Placebo for treatment period
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed