Breast NeoplasmsPhase 2NCT02580279
Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
A Phase 2 study testing EGCG in people with Breast Neoplasms and Dermatitis, run by Shandong Cancer Hospital and Institute.
Trial summary
The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Neoplasms, Dermatitis, Prevention & Control
- What is being tested?
- EGCG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2019
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ eighteen years
- Eastern Cooperative Oncology Group performance status of 0-1
- Normal hematologic, hepatic function and renal values
- Forced expiratory volume 1 >800 cc
Who cannot join
- The presence of rash or unhealed wound in the radiation field
- A known allergy or hypersensitivity to EGCG
- Pregnancy or lactation
- History of/current connective tissue disorder
- Prior radiation to the thorax
About this study
Official title: Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
- Being tested
- EGCG, placebo
- Keywords
- Breast Neoplasms, prevention & control, Epigallocatechin gallate, Dermatitis
- Medical subject headings
- Breast Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCGDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| EGCG group | Experimental | EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy. Receives: Drug: EGCG |
| placebo | Placebo comparator | The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation
Measured: Each patient will be enrolled for a 5-6 week trial
Secondary outcomes (2)
Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation
Measured: Each patient will be enrolled for a 5-6 week trial
Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer
questionnaire
Measured: Each patient will be enrolled for a 5-6 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
- Investigators
- Ligang Xing, MD,PhD, Study chair, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580279
- Sponsor's protocol ID
- GTEBC-2015
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2015
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Xie J, Jia L, Xie P, Yin X, Zhu W, Zhao H, Wang X, Meng X, Xing L, Zhao H, Li X. Efficacy and safety of epigallocatechin-3-gallate in treatment acute severe dermatitis in patients with cancer receiving radiotherapy: a phase I clinical trial. Sci Rep. 2023 Aug 24;13(1):13865. doi: 10.1038/s41598-023-40881-4.
PubMed 37620508Zhao H, Zhu W, Zhao X, Li X, Zhou Z, Zheng M, Meng X, Kong L, Zhang S, He D, Xing L, Yu J. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):779-786. doi: 10.1001/jamadermatol.2022.1736.
PubMed 35648426
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT02580279
- Acronym / sponsor ID
- GTEBC-2015
- Keywords
- Breast Neoplasms, prevention & control, Epigallocatechin gallate, Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 20 Oct 2015 (estimated)
- 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.
The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGCG group | Experimental | Drug: EGCGEGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy. |
| placebo | Placebo comparator | Drug: placeboThe placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ eighteen years
- Eastern Cooperative Oncology Group performance status of 0-1
- Normal hematologic, hepatic function and renal values
- Forced expiratory volume 1 >800 cc
Key exclusion criteria (5 listed)
- The presence of rash or unhealed wound in the radiation field
- A known allergy or hypersensitivity to EGCG
- Pregnancy or lactation
- History of/current connective tissue disorder
- Prior radiation to the thorax
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 |
|---|---|---|
| EGCG | Drug | EGCG group |
| placebo | Drug | placebo |
Primary outcome
Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation
Time frame: Each patient will be enrolled for a 5-6 week trial
2 secondary outcomes
Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation
Time frame: Each patient will be enrolled for a 5-6 week trial
Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer
Time frame: Each patient will be enrolled for a 5-6 week trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 37620508Xie J, Jia L, Xie P, Yin X, Zhu W, Zhao H, Wang X, Meng X, Xing L, Zhao H, Li X. Efficacy and safety of epigallocatechin-3-gallate in treatment acute severe dermatitis in patients with cancer receiving radiotherapy: a phase I clinical trial. Sci Rep. 2023 Aug 24;13(1):13865. doi: 10.1038/s41598-023-40881-4.
- Derived from this study: PubMed 35648426Zhao H, Zhu W, Zhao X, Li X, Zhou Z, Zheng M, Meng X, Kong L, Zhang S, He D, Xing L, Yu J. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):779-786. doi: 10.1001/jamadermatol.2022.1736.
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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.
Ligang Xing, MD,PhD study chair
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGCG in people with Breast Neoplasms and Dermatitis, run by Shandong Cancer Hospital and Institute.
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 4 inclusion and 5 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation (time frame: Each patient will be enrolled for a 5-6 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580279, which also lists 2 linked publications.
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 5 Apr 2019.