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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02580279
• Other study ID #: GTEBC-2015
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: October 2019

Study information

• Verified date: April 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Dermatitis
• Epigallocatechin Gallate
• Prevention & Control

Intervention

Drug:
• EGCG

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Each patient will be enrolled for a 5-6 week trial
Secondary	Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation		Each patient will be enrolled for a 5-6 week trial
Secondary	Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer	questionnaire	Each patient will be enrolled for a 5-6 week trial