CClinicalTrials.gg
RecruitingNCT06524609Updated Jul 29, 2024

EGCG for the Prevention and Treatment of TIPN

A Phase 1/2 interventional study of Epigallocatechin-3-Gallate and Alcohol in Chemotherapy-induced Peripheral Neuropathy, sponsored by Han Xi Zhao. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Han Xi Zhao · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Nov 2023, registered Jun 2024).
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy

Keywords

  • peripheral neurotoxicity
  • Chemotherapy-Induced Peripheral Neuropathy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's planned enrollment of 36 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

This is the only study on the registry with Han Xi Zhao as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    CONTROL GROUP

    75% alcohol

    Drug: Alcohol

Interventions

  • DrugEpigallocatechin-3-Gallate

    After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).

  • DrugAlcohol

    After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).

06

What researchers measure

Primary outcomes

  1. sensory nerves and motor nerves of CTCAE

    CTCAE(Common Terminology Criteria for Adverse Events): A minimum of 1 grade and maximum of 5 grades.

    Time frame: 42 days

  2. TNS(Total Neuropathy Score)

    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.

    Time frame: 42 days

  3. EORTC Scale(European Organization for Research and Treatment of Cancer TIPN-specific Quality of Life Quality of Life Questionnaire for CIPN)

    The scale consists of 9 scales for sensory, motor, and autonomic nerves, same grading and calculation method as the TNS scale.

    Time frame: 42 days

07

Study locations

1 of 1 sites recruiting
  • Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
    Jinan, Shandong 250117, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06524609
Lead sponsor
Han Xi Zhao
Collaborators
The Fourth People's Hospital of Jinan
Responsible party
Han Xi Zhao (chief physician, Shandong Cancer Hospital and Institute) — Sponsor-investigator
First posted
Jul 29, 2024
Start date
Nov 30, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Jan 30, 2025 (estimated)
Last update
Jul 29, 2024

Study contacts

Hanxi Zhao, Dr.
Contact
zhx7152028@126.com
86-053167626995
Hanxi Zhao, Dr.
study director · Institute of Radiation Medicine, Shandong First Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion