EGCG for the Prevention and Treatment of TIPN

NCT06524609 | Recruiting Phase 1 DMC

• 1 other identifier: EGCG-TIPN
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

peripheral neurotoxicity; Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• sensory nerves and motor nerves of CTCAE

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

  42 days

• 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.

  42 days

• 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.

  42 days

Study Arms (2)

EGCG GROUP

EXPERIMENTAL

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

CONTROL GROUP

PLACEBO COMPARATOR

75% alcohol

Drug: Alcohol

Interventions

Epigallocatechin-3-Gallate DRUG

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

EGCG GROUP

Alcohol DRUG

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

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Han Xi Zhao: lead
• The Fourth People's Hospital of Jinan: collaborator

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

epigallocatechin gallate; Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Hanxi Zhao, Dr.

  Institute of Radiation Medicine, Shandong First Medical University

  STUDY DIRECTOR

Central Study Contacts

Hanxi Zhao, Dr.

CONTACT

86-053167626995; zhx7152028@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 29, 2024
• Study Start: November 30, 2023
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)