Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYan Yang, MD, Ph.D
About this trial
The study is to evaluate the efficacy and safety of duloxetine in Chinese solid tumor patients with taxanes-induced painful peripheral neuropathy. Duloxetine will be given to patients who have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and at least 4 on a scale of 0 to 10 points, representing average chemotherapy-induced pain, after taxanes treatment. Patient-reported pain severity, functional interference, emotion condition and quality of Life will be assessed weekly using corresponding scales. Blood samples will be collected from each enrolled subjects before the start of treatment, and the potential biomarkers in predicting duloxetine efficacy or safety will be explored by genomic profiling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center;
Patients must received treatment with a chemotherapy regimen containing taxanes;
Disqualifiers
Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product;
Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels;
Patients who must take monoamine oxidase inhibitors for antidepressant treatment；
Patients with the presence of active brain or meningeal metastases；
Trial design
Design model
Single group
Treatments tested in this trial
Duloxetine
DrugDuloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily. Taxanes is used according to manual instruction and patient condition.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Duloxetine armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Score
Scale title: Brief Pain Inventory Short Form (BPI-SF). Description: Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine).
Time frame
Once every 7 days after treatment initiation.Secondary outcomes
1
Quality of Life Score
Scale title: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Description: Items in FACT/GOG-Ntx are scored using an 5-point numeric rating scale (0, not at all; 4, very much).
Time frame
Once every 7 days after treatment initiation.2
Function Score
Scale title: Brief Pain Inventory Short Form (BPI-SF). Description: Degree of pain-related functional interference is based on partial items in the BPI-SF and scored using an 11-point numeric rating scale, (0, does not interfere; 10, completely interferes).
Time frame
Once every 7 days after treatment initiation.3
Anxiety and depression Score
Scale 1 title: Hamilton Anxiety Rating Scale (HAM-A) Description: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Scale 2 title: Hamilton Depression Rating Scale (HDRS17) Description: HDRS17 uses a 5-point scale of 0 to 4 for most items and a 3-point scale of 0 to 2 for a few items, and higher scores mean a worse symptom. The total scores less than 7 or 7 are indicative of the absence of depression or being normal, 8-16 consider mild depression, 17-23 suggest moderate depression and scores 24 or over are indicative of severe depression.
Time frame
Once every 7 days after treatment initiation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Yang, MD, Ph.D
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Sponsor institution
Source ClinicalTrials.gov