Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Sponsor
Mansoura University
Study ID
NCT05884281
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    0.5 mg once daily for treatment period
  • Placebo — DRUG
    Placebo for treatment period

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
May 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intervention
  • Placebo Comparator: Control

Primary Outcome Measure

Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria [ Time Frame: 8 weeks post intervention ]

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