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

A Single-Center, Single-Arm Clinical Trail Evaluating Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy

Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy (NCT04970121) is a Phase 2 interventional studying Chemotherapy-induced Peripheral Neuropathy and Pain, sponsored by Yan Yang, MD, Ph.D. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chemotherapy-induced Peripheral Neuropathy and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chemotherapy-induced Peripheral Neuropathy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients must sign an willing to sign a consent form form (ICF) voluntarily and be able to understand and comply with the requirements of the study; 2. Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the willing to sign a consent form form, regardless of gender; 3. Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center; 4. Patients must received treatment with a chemotherapy regimen containing taxanes; 5. 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 6. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2; 7. Expected survival of ≥ 3 months; 8. 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); 9. Female patients who are non-lactating and must have a negative pregnancy test result; 10. Patients of childbearing potential must agree to use effective contraception for at least 30 days after signing the willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study; 2. Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender; 3. Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center; 4. Patients must received treatment with a chemotherapy regimen containing taxanes; 5. 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 6. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2; 7. Expected survival of ≥ 3 months; 8. 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); 9. Female patients who are non-lactating and must have a negative pregnancy test result; 10. 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: 1. Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product; 2. Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels; 3. Patients who must take monoamine oxidase inhibitors for antidepressant treatment； 4. Patients with the presence of active brain or meningeal metastases； 5. Patients with the presence of uncontrolled closed-angle glaucoma； 6. Patients with the presence of neuropathy caused by any type of nerve compression； 7. 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; 8. 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; 9. Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study； 10. Patients are excluded from the study if investigator/sponsor believes that participation in the study is not in the subject's best interest.

Treatments Being Tested

DRUG

Duloxetine

Duloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily. Taxanes is used according to manual instruction and patient condition.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jing Liu

Bengbu, Anhui, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04970121), the sponsor (Yan Yang, MD, Ph.D), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04970121 clinical trial studying?

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 wil… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04970121?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04970121?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04970121. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04970121. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.