BridgeMD
Prevention study for Chemotherapy-induced Peripheral Neuropathy
Official title EGCG for the Prevention and Treatment of TIPN
ClinicalTrials.gov ID: NCT06524609
What this study is testing
What is Epigallocatechin-3-Gallate?
Epigallocatechin-3-Gallate is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people of childbearing potential
You likely can't join if
- The presence of a pre-existing condition that may result in a high risk of neuropathy: diabetes mellitus, thyroid disease, prior treatment with other...
- Concurrent enrollment in another clinical study, unless it is an observational, non-treatment clinical study or a follow-up period of an treatment...
- Have taken medication for the treatment or prevention of peripheral neuropathy in the 2 weeks prior to screening, or have received traditional...
- Known active tuberculosis (TB): people 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.
See the full eligibility 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 people of childbearing potential
- people were willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and compliance with other requirements of the study.
- 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...
- Concurrent enrollment in another clinical study, unless it is an observational, non-treatment clinical study or a follow-up period of an treatment 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...
- Known active tuberculosis (TB): people 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...
- 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...
- Be pregnant or breastfeeding, or plan to breastfeed during the study. Other conditions that the investigator considers inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.