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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

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06091553
Collaborator
(none)
160
Enrollment
4
Arms
14.4
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Duloxetine alone
  • Drug: Duloxetine augmented with gabapentin
  • Drug: Duloxetine augmented with amitriptyline (as combined therapy)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Duloxetine alone (as monotherapy)

Duloxetine alone (as monotherapy)

Drug: Duloxetine alone
30 mg once daily for 1 week, then 60 mg once daily
Active Comparator: Duloxetine augmented with gabapentin (as combined therapy)

Duloxetine augmented with gabapentin (as combined therapy)

Drug: Duloxetine augmented with gabapentin
30 mg once daily for 1 week, then 60 mg once daily 300 mg at bedtime
Active Comparator: Duloxetine augmented with amitriptyline (as combined therapy)

Duloxetine augmented with amitriptyline (as combined therapy)

Drug: Duloxetine augmented with amitriptyline (as combined therapy)
10 to 25 mg once daily at bedtime 30 mg once daily for 1 week, then 60 mg once daily
No Intervention: control

control

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Quality of Life Score [8 week]

  2. Anxiety and depression Score [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hager salah el din, hager salah, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT06091553
Other Study ID Numbers:
  • IORG0006240
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Gabapentin
Duloxetine Hydrochloride
Amitriptyline

Study Results

No Results Posted as of Oct 19, 2023