Using EGCG to treat nerve damage from chemotherapy
Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane (TIPN)
This study is testing if a topical solution made from green tea extract can help people who have nerve damage from chemotherapy feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06524609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of epigallocatechin-3-gallate (EGCG) solution to prevent and treat chemotherapy-induced peripheral neuropathy (CIPN) in patients who have received albumin-bound paclitaxel. Initially, a phase I trial assessed the safety and optimal concentration of EGCG, followed by a phase II trial to evaluate its efficacy in reducing the severity of CIPN. Patients with grade II or higher CIPN will receive topical EGCG applied to affected areas, with the treatment's effectiveness measured through various clinical scales. The study also aims to identify predictive biomarkers related to the efficacy of EGCG treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed cancer who have experienced grade II or higher CIPN after receiving albumin-bound paclitaxel.
Not a fit: Patients with pre-existing conditions that increase the risk of neuropathy or those currently enrolled in other clinical studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate nerve damage symptoms in patients undergoing chemotherapy.
How similar studies have performed: While the use of EGCG in this context is relatively novel, previous studies have shown potential benefits of EGCG in neuroprotection, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Jinan, Shandong
- Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences) — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Hanxi Zhao, Dr.
- Email: zhx7152028@126.com
- Phone: 86-053167626995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.