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

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Epigallocatechin gallate

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