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Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Roflumilast
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05884281
    Brief Title
    Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
    Official Title
    Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Neuropathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Roflumilast
    Intervention Description
    0.5 mg once daily for treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo for treatment period
    Primary Outcome Measure Information:
    Title
    Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
    Description
    Number of patients reported neuropathy from paclitaxel
    Time Frame
    8 weeks post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

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