EGCG for the Prevention and Treatment of TIPN

July 26, 2024 updated by: Han Xi Zhao

Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane (TIPN)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 well as the EORTC-CIPN20 scale. EGCG was purchased from HEP Biotech Co., Ltd (Ningbo, Zhejiang, China) and freshly dissolved in 75% alcohol by volume. EGCG concentrations were climbed from 1% according to the modified Fibonacci method for 4 dose groups. EGCG administration was initiated when Grade II CIPN occurred first time. EGCG solution is applied to the patient's hands/feet with a soft-bristled brush, approximately 0.05 ml/cm2. 3 times daily, and may be covered with film gloves/cling film for approximately 20-30 minutes after application. Use continuously for at least 1 week. By comparing and analyzing the degree of reduction in CECAE, TNS, and EORTC scale data before and after EGCG treatment in patients with degree II CIPN, the optimal EGCG drug dosing concentration was obtained to validate safety. The EGCG concentration obtained from the phase I trial was also used to prospectively conduct a randomized controlled phase II clinical trial to further validate the efficacy.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGCG GROUP
EGCG administration was initiated when Grade II CIPN occurred first time. EGCG solution is applied to the patient's hands/feet with a soft-bristled brush, approximately 0.05 ml/cm2. 3 times daily, and may be covered with film gloves/cling film for approximately 20-30 minutes after application. Use continuously for at least 1 week.
Drug: Epigallocatechin-3-Gallate
After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).
Placebo Comparator: CONTROL GROUP
75% alcohol
Drug: Alcohol
After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory nerves and motor nerves of CTCAE
Time Frame: 42 days
CTCAE（Common Terminology Criteria for Adverse Events）: A minimum of 1 grade and maximum of 5 grades.
42 days
TNS（Total Neuropathy Score）
Time Frame: 42 days
TNS（Total Neuropathy Score）: Including sensory nerves, motor nerves and tendon reflexes, etc., 10 indicators, with a minimum of 1 grade and maximum of 5 grades each, and the scores of the 10 indicators were added together for a total.
42 days
EORTC Scale（European Organization for Research and Treatment of Cancer TIPN-specific Quality of Life Quality of Life Questionnaire for CIPN）
Time Frame: 42 days
The scale consists of 9 scales for sensory, motor, and autonomic nerves, same grading and calculation method as the TNS scale.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Han Xi Zhao

Collaborators

The Fourth People's Hospital of Jinan

Investigators

  • Study Director: Hanxi Zhao, Dr., Institute of Radiation Medicine, Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGCG-TIPN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-induced Peripheral Neuropathy

Clinical Trials on Epigallocatechin-3-Gallate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe