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Tests treatment safety and results for Chemotherapy-induced Peripheral Neuropathy
Official title Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy
ClinicalTrials.gov ID: NCT04970121
What this study is testing
What is Duloxetine?
Duloxetine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Also referred to as Chemotherapy containing taxanes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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；
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.