Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

NCT05884281 | Unknown Phase 1 DMC

• 1 other identifier: 8/2023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks post intervention

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Drug: Roflumilast

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Roflumilast DRUG

0.5 mg once daily for treatment period

Intervention

Placebo DRUG

Placebo for treatment period

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05