Actively Recruiting
Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy
Led by Yan Yang, MD, Ph.D · Updated on 2024-09-25
100
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must sign an informed consent form and be able to understand and comply with study requirements
- Patients aged 18 to 75 years at the time of consent, any gender
- Diagnosed with malignant solid tumors by pathology or cytology
- Received chemotherapy including taxanes
- Have grade 1 or higher sensory chemotherapy-induced peripheral neuropathy with an average pain score of 4 or more on a 0 to 10 scale
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Expected survival of at least 3 months
- Screening lab values within required limits: neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 90 × 10^9/L, hemoglobin ≥ 90 g/L; liver enzymes and bilirubin no more than twice the upper normal limit; normal renal function
- Female patients must be non-lactating and have a negative pregnancy test
- Patients of childbearing potential must agree to use effective contraception for at least 30 days after consent
- Stable doses of allowed analgesics during the two weeks prior to enrollment
You will not qualify if you...
- Known allergy to duloxetine or its ingredients
- Taking medications that affect 5-hydroxytryptamine (5-HT) levels
- Need to take monoamine oxidase inhibitors for depression treatment
- Have active brain or meningeal metastases
- Have uncontrolled closed-angle glaucoma
- Neuropathy from nerve compression
- Mental illness, epilepsy, mania, suicidal depression, dementia, or substance abuse affecting study compliance
- Cardiovascular diseases including heart failure (NYHA ≥ grade 2), severe angina, recent heart attack or stroke (within 6 months), arrhythmias requiring treatment, superior vena cava syndrome, prolonged QT interval, or uncontrolled hypertension
- Other medical conditions that could interfere with study results
- Investigator or sponsor believes participation is not in the patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jing Liu
Bengbu, Anhui, China, 233004
Actively Recruiting
Research Team
J
Jing Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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