Actively Recruiting
EGCG for the Prevention and Treatment of TIPN
Led by Han Xi Zhao · Updated on 2024-07-29
36
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
H
Han Xi Zhao
Lead Sponsor
T
The Fourth People's Hospital of Jinan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients treated with paclitaxel analogs and experiencing Taxane-induced peripheral neurotoxicity (TIPN) of degree I or higher were treated with EGCG solution. The safety of topical EGCG solution for the treatment of TIPN and the optimal drug concentration were also verified by a phase I trial. The efficacy and safety of the optimal EGCG concentration obtained in the phase I trial were further analyzed in a randomized controlled phase II trial. Meanwhile, the predictive molecules of TIPN efficacy were initially explored by detecting patients' hematological related indexes. The optimal dose concentration, safety and efficacy of EGCG to ameliorate the neurotoxicity caused by paclitaxel-related drugs were clarified.
CONDITIONS
Official Title
EGCG for the Prevention and Treatment of TIPN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed cancer
- Received at least 1 cycle of systemic chemotherapy with albumin-bound paclitaxel
- Adequate hematologic, hepatic, and kidney function profile
- Chemotherapy-induced peripheral neuropathy evaluated as grade 2 or higher by CTCAE
- Urine or serum pregnancy test within 3 days before first dose for females of childbearing potential
- Willing and able to comply with study visits, treatment protocols, lab tests, and other study requirements
You will not qualify if you...
- Pre-existing conditions with high neuropathy risk: diabetes, thyroid disease, prior neurotoxic medication, alcoholism, familial neuropathy
- Concurrent enrollment in another clinical interventional study (except observational or follow-up studies)
- Use of medication for peripheral neuropathy treatment or prevention within 2 weeks prior to screening, or traditional Chinese medicine within 1 month
- Known active tuberculosis or suspected active TB without clinical exclusion
- Known active syphilis infection
- Allergy to any study drug component including alcohol
- History of mental illness, drug dependence, alcoholism, or drug addiction
- Medical condition, treatment, or lab abnormality that could interfere with study participation or results
- Localized or systemic disease not caused by cancer that increases medical risk or affects survival evaluation
- Weight loss of more than 10% in 3 months prior to screening
- Pregnant or breastfeeding, or planning to breastfeed during the study
- Other conditions deemed inappropriate for enrollment by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
H
Hanxi Zhao, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here