Actively Recruiting
ADC-induced Neurotoxicity Treated With Duloxetine
Led by Fudan University · Updated on 2024-09-19
37
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is effective in treating peripheral neuropathy caused by antibody-drug conjugate. PURPOSE: This single arm phase II trial is studying duloxetine to see how well it works in treating peripheral neuropathy caused by antibody-drug conjugate in patients with cancer.
CONDITIONS
Official Title
ADC-induced Neurotoxicity Treated With Duloxetine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosis of advanced cancer confirmed by histological or cytological examination combined with imaging or ultrasound
- Consent to receive treatment
- ECOG performance status score of 0 to 2
- Experienced grade 2 or higher peripheral neuropathy caused by an ADC drug lasting more than 28 days with tumor stable and no use of drugs causing neuropathy for 2 months
- Adequate organ function including specified blood counts, liver function tests, and renal function
- Predicted survival of at least 3 months with stable tumor
- Ability to comply with study visits and protocol requirements
You will not qualify if you...
- Peripheral neuropathy of grade 2 or higher caused by platinum or paclitaxel chemotherapy before ADC treatment without worsening
- Severe diabetes mellitus or peripheral vascular disease
- History of neuropathy from nerve compression or severe psychiatric conditions including depression, bipolar disorder, or alcoholism
- Active or uncontrolled serious infections requiring systemic therapy
- Active hepatitis or specified viral hepatitis levels unless stabilized with antiviral therapy
- Renal failure requiring dialysis
- Immunodeficiency including HIV or history of organ transplantation
- Severe symptoms such as nausea, headache, fatigue, or dizziness
- History of active tuberculosis
- Uncontrolled ascites, pericardial or pleural effusion requiring repeated drainage
- Recent major surgery, incisional biopsy, or significant trauma within 28 days
- Severe hypersensitivity reactions to monoclonal antibodies or study drug ingredients
- Participation in other clinical trials within 4 weeks prior to study
- History of severe allergy
- Bleeding risk, coagulation disorders, or on thrombolytic therapy
- History of psychotropic substance abuse or psychiatric disorders
- Medical conditions that jeopardize safety or interfere with study completion as judged by investigator
- Neurological or psychiatric disorders such as dementia or epilepsy
- Serious or unstable medical or psychological conditions interfering with consent or study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Cancer center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Sheng Zhang, PhD
CONTACT
H
Hongxia Wang, PhD
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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