Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884281

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy	Drug: Roflumilast Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention	Drug: Roflumilast 0.5 mg once daily for treatment period
Placebo Comparator: Control	Drug: Placebo Placebo for treatment period

Arm

Intervention/Treatment

Active Comparator: Intervention

Drug: Roflumilast

0.5 mg once daily for treatment period

Placebo Comparator: Control

Drug: Placebo

Placebo for treatment period

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noha Mansour, Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University

ClinicalTrials.gov Identifier:

NCT05884281

Other Study ID Numbers:

8/2023

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Jun 1, 2023