Chemotherapy-induced Peripheral NeuropathyPhase 1/2NCT06524609
EGCG for the Prevention and Treatment of TIPN
A Phase 1/2 study testing Epigallocatechin-3-Gallate and Alcohol in people with Chemotherapy-induced Peripheral Neuropathy, run by Han Xi Zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Epigallocatechin-3-Gallate and Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 30 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)
Jinan, Shandong, 250117
Hanxi Zhao, MD, 86-531-67626996, zhx87520052@163.com
About this study
Official title: 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.
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.
- Being tested
- Epigallocatechin-3-Gallate, Alcohol
- Keywords
- peripheral neurotoxicity, Chemotherapy-Induced Peripheral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin-3-GallateDrug
After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).
AlcoholDrug
After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Epigallocatechin-3-Gallate |
| CONTROL GROUP | Placebo comparator | 75% alcohol Receives: Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory nerves and motor nerves of CTCAE
CTCAE（Common Terminology Criteria for Adverse Events）: A minimum of 1 grade and maximum of 5 grades.
Measured: 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.
Measured: 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.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start30 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Xi Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth People's Hospital of Jinan
- Responsible party
- Sponsor-investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
- Investigators
- Hanxi Zhao, Dr., Study director, Institute of Radiation Medicine, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524609
- Sponsor's protocol ID
- EGCG-TIPN
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane (TIPN)
- ClinicalTrials.gov ID
- NCT06524609
- Acronym / sponsor ID
- EGCG-TIPN
- Keywords
- peripheral neurotoxicity, Chemotherapy-Induced Peripheral Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Han Xi ZhaoUniversity, hospital or other
- Collaborators
- The Fourth People's Hospital of Jinan
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGCG GROUP | Experimental | Drug: Epigallocatechin-3-GallateEGCG 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. |
| CONTROL GROUP | Placebo comparator | Drug: Alcohol75% alcohol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigallocatechin-3-GallateAfter determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol). | Drug | EGCG GROUP |
| AlcoholAfter determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol). | Drug | CONTROL GROUP |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanxi Zhao, Dr. study director
Institute of Radiation Medicine, Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epigallocatechin-3-Gallate and Alcohol in people with Chemotherapy-induced Peripheral Neuropathy, run by Han Xi Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanxi Zhao, Dr. (86-053167626995, zhx7152028@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory nerves and motor nerves of CTCAE (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.