EGCG for the Prevention and Treatment of TIPN
Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane (TIPN)
Han Xi Zhao
36 participants
Nov 30, 2023
INTERVENTIONAL
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 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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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.
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Interventions
After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).
After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06524609