Phase
Condition
Neurologic Disorders
Treatment
Epigallocatechin-3-Gallate
Alcohol
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 subjectsof childbearing potential
Subjects were willing and able to comply with the schedule of visits, treatmentprotocols, laboratory tests, and compliance with other requirements of the study.
Exclusion
Exclusion Criteria:
The presence of a pre-existing condition that may result in a high risk ofneuropathy: diabetes mellitus, thyroid disease, prior treatment with othermedications 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 inthe 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 beexcluded 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 testabnormality that may confound the results of the study, interfere with the subject'sability to participate in the study in its entirety, or participation in the studymay not be in the subject's best interest.
Localized or systemic disease not due to malignancy; or disease or conditionsecondary to a tumor that may result in a higher medical risk and/or uncertainty inthe evaluation of survival, such as tumor-like leukemic reaction (white blood cellcount >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. Otherconditions that the investigator considers inappropriate for enrollment.
Study Design
Study Description
Connect with a study center
Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
Jinan, Shandong 250117
ChinaActive - Recruiting
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