Status:
RECRUITING
EGCG for the Prevention and Treatment of TIPN
Lead Sponsor:
Han Xi Zhao
Collaborating Sponsors:
The Fourth People's Hospital of Jinan
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
Enrolled patients with tumors that developed CIPN of degree II or greater who received albumin-bound paclitaxel chemotherapy. The baseline degree of CIPN in patients was evaluated by CTCAE and TNS as ...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed cancer
- Received ≥1 cycle of systemic chemotherapy with albumin-bound paclitaxel
- Adequate hematologic, hepatic, and kidney function profile
- CIPN was evaluated by CTCAE as grade ≥2
- Urine or serum pregnancy test within 3 days prior to first dose in female subjects of childbearing potential
- Subjects were willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and compliance with other requirements of the study.
Exclusion
- The presence of a pre-existing condition that may result in a high risk of neuropathy: diabetes mellitus, thyroid disease, prior treatment with other medications that may result in neurological damage, alcoholism, familial neuropathy
- Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study
- Have taken medication for the treatment or prevention of peripheral neuropathy in the 2 weeks prior to screening, or have received traditional Chinese medicine (acupuncture, moxibustion, herbal medicine, cupping) within 1 month
- Known active tuberculosis (TB): Subjects suspected of having active TB need to be excluded by clinical examination.
- Known active syphilis infection.
- Known allergy to any component of any study drug; including alcohol allergy.
- Known history of mental illness, drug dependence, alcoholism or drug addiction.
- Any pre-existing or current medical condition, treatment, or laboratory test abnormality that may confound the results of the study, interfere with the subject's ability to participate in the study in its entirety, or participation in the study may not be in the subject's best interest.
- Localized or systemic disease not due to malignancy; or disease or condition secondary to a tumor that may result in a higher medical risk and/or uncertainty in the evaluation of survival, such as tumor-like leukemic reaction (white blood cell count \>20 x 109/L), malignant manifestations (e.g., known weight loss of more than 10% in the 3 months prior to Screening).
- Be pregnant or breastfeeding, or plan to breastfeed during the study. Other conditions that the investigator considers inappropriate for enrollment.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06524609
Start Date
November 30 2023
End Date
January 30 2025
Last Update
July 29 2024
Active Locations (1)
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1
Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
Jinan, Shandong, China, 250117