Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy

  • End date
    Jan 1, 2024
  • participants needed
  • sponsor
    Yan Yang, MD, Ph.D
Updated on 30 August 2021


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.

Condition Pain (Pediatric), Solid Neoplasm, Chemotherapy Induced Peripheral Neuropathy, Pain, Solid Tumour, ache, Acute Pain Service, Solid Tumor, Post-Surgical Pain, Solid Tumors
Treatment Duloxetine
Clinical Study IdentifierNCT04970121
SponsorYan Yang, MD, Ph.D
Last Modified on30 August 2021


Yes No Not Sure

Inclusion Criteria

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
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
Screening values at screening meet the following requirements: (no blood components, cell growth factors, leukocyte-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc. are allowed within 14 days prior to obtaining laboratory tests); Complete blood count: neutrophil count (ANC) 1.5 109/L, platelet count (PLT) 90 109/L, hemoglobin (Hb) 90 g/L; Liver function: glutamic aminotransferase (AST), alanine aminotransferase (ALT) and total serum bilirubin (TBIL) 2 times the upper limit of normal range (ULN) Renal function: serum creatinine (Cr) ULN or creatinine clearance (CCr) 80 mL/min (applying the standard Cockcroft -Gault formula)
Female patients who are non-lactating and must have a negative pregnancy test result
Patients of childbearing potential must agree to use effective contraception for at least 30 days after signing the informed consent to the last dose
Note: Concomitant use of selected analgesics (e.g., opioids, acetaminophen
aspirin, and other NSAIDs) is permitted, but only patients receiving a stable
dose during the two weeks prior to enrollment may participate

Exclusion Criteria

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
Patients with the presence of uncontrolled closed-angle glaucoma
Patients with the presence of neuropathy caused by any type of nerve compression
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
Patients are excluded from the study if investigator/sponsor believes that participation in the study is not in the subject's best interest
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note