Duloxetine for treating painful nerve damage in cancer patients after taxane chemotherapy

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

This study is testing if duloxetine can help Chinese cancer patients with painful nerve damage caused by chemotherapy feel better and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Bengbu Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bengbu, Anhui)
• Trial ID: NCT04970121 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of duloxetine in Chinese patients with solid tumors who are experiencing painful peripheral neuropathy induced by taxane chemotherapy. Participants will be those with grade 1 or higher sensory neuropathy and significant pain levels. The study will assess patient-reported pain severity, functional interference, emotional condition, and quality of life on a weekly basis. Additionally, blood samples will be collected to explore potential biomarkers that may predict the efficacy or safety of duloxetine treatment.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 to 75 with solid tumors who have experienced painful peripheral neuropathy after taxane chemotherapy.

Not a fit: Patients who do not have chemotherapy-induced peripheral neuropathy or those with less than grade 1 sensory neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients suffering from chemotherapy-induced peripheral neuropathy.

How similar studies have performed: Other studies have shown promising results with duloxetine for neuropathic pain, suggesting potential success for this approach in a similar patient population.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui

• Jing Liu — Bengbu, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Yan Yang, M.D.,Ph.D — First Affiliated Hospital of Bengbu Medical College
• Study coordinator: Jing Liu, M.D.

Conditions Chemotherapy-induced Peripheral Neuropathy; Pain; Solid Tumor; Duloxetine; Taxanes; Solid tumor