## Protocol Section
### Identification Module
**NCT ID:** NCT02580279

**Brief Title:** Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

**Official Title:** Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

#### Organization Study ID Info
**ID:** GTEBC-2015
#### Organization
**Class:** OTHER
**Full Name:** Shandong Cancer Hospital and Institute
### Status Module
#### Completion Date
**Date:** 2019-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2019-04-05

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-03

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-12

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2015-10-20
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-27
**Study First Submit QC Date:** 2015-10-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shandong Cancer Hospital and Institute

#### Responsible Party

**Investigator Affiliation:** Shandong Cancer Hospital and Institute

**Investigator Full Name:** Han Xi Zhao

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Breast Neoplasms

- Dermatitis

- Prevention & Control

- Epigallocatechin Gallate

**Keywords:**

- Breast Neoplasms

- prevention & control

- Epigallocatechin gallate

- Dermatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 68

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: EGCG

**Label:** EGCG group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.

**Intervention Names:**

- Drug: placebo

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- EGCG group

**Name:** EGCG

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- placebo

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** 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

**Description:** questionnaire

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Shandong Cancer Hospital and Institute

**Name:** Ligang Xing, MD,PhD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Zhao 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.

**PMID:** 35648426

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2022-03-14

- Date Unknown: Unknown

#### Event: RESET

- Date: 2022-07-12

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000012871

- Term: Skin Diseases

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001941

- Term: Breast Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Neoplasms

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000003872

- Term: Dermatitis

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Fl

- Name: Flavonoid

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M159487

- Name: Epigallocatechin gallate

- Relevance: LOW

- As Found: Unknown

- ID: T27

- Name: Epigallocatechin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2022-03-14

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2022-03-14

- Reset Date: 2022-07-12

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
