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Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy

Primary Purpose

Neuropathy in Cacer Patien

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Duloxetine alone
Duloxetine augmented with gabapentin
Duloxetine augmented with amitriptyline (as combined therapy)
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy in Cacer Patien

Eligibility Criteria

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

Inclusion Criteria: -Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology. Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study; Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender; Patients must received treatment with a chemotherapy regimen . Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2; Expected survival of ≥ 3 months There is no maximum number of prior medical therapies. Exclusion Criteria: History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin Pregnant women are excluded from this study. Life expectancy less than 6 months Inability or unwillingness to comply with research protocols. Patients with the presence of active brain or meningeal metastases. Patients with the presence of uncontrolled closed-angle glaucoma. Patients with the presence of neuropathy caused by any type of nerve compression as diabetes. The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements. The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Duloxetine alone (as monotherapy)

    Duloxetine augmented with gabapentin (as combined therapy)

    Duloxetine augmented with amitriptyline (as combined therapy)

    control

    Arm Description

    Duloxetine alone (as monotherapy)

    Duloxetine augmented with gabapentin (as combined therapy)

    Duloxetine augmented with amitriptyline (as combined therapy)

    control

    Outcomes

    Primary Outcome Measures

    The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.

    Secondary Outcome Measures

    Quality of Life Score
    Anxiety and depression Score

    Full Information

    First Posted
    October 14, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091553
    Brief Title
    Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy
    Official Title
    Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Duloxetine alone (as monotherapy)
    Arm Type
    Active Comparator
    Arm Description
    Duloxetine alone (as monotherapy)
    Arm Title
    Duloxetine augmented with gabapentin (as combined therapy)
    Arm Type
    Active Comparator
    Arm Description
    Duloxetine augmented with gabapentin (as combined therapy)
    Arm Title
    Duloxetine augmented with amitriptyline (as combined therapy)
    Arm Type
    Active Comparator
    Arm Description
    Duloxetine augmented with amitriptyline (as combined therapy)
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    control
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine alone
    Intervention Description
    30 mg once daily for 1 week, then 60 mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine augmented with gabapentin
    Intervention Description
    30 mg once daily for 1 week, then 60 mg once daily 300 mg at bedtime
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine augmented with amitriptyline (as combined therapy)
    Intervention Description
    10 to 25 mg once daily at bedtime 30 mg once daily for 1 week, then 60 mg once daily
    Primary Outcome Measure Information:
    Title
    The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
    Time Frame
    8 week
    Secondary Outcome Measure Information:
    Title
    Quality of Life Score
    Time Frame
    8 week
    Title
    Anxiety and depression Score
    Time Frame
    8 weeks

    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: -Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology. Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study; Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender; Patients must received treatment with a chemotherapy regimen . Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2; Expected survival of ≥ 3 months There is no maximum number of prior medical therapies. Exclusion Criteria: History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin Pregnant women are excluded from this study. Life expectancy less than 6 months Inability or unwillingness to comply with research protocols. Patients with the presence of active brain or meningeal metastases. Patients with the presence of uncontrolled closed-angle glaucoma. Patients with the presence of neuropathy caused by any type of nerve compression as diabetes. The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements. The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hager salah
    Phone
    0097336679556
    Email
    hager.salah@rocketmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed hassan
    Phone
    01061246789
    Email
    ahmedhassan_dr@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy

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