Breast Neoplasms, Dermatitis, Epigallocatechin Gallate, Prevention & Control
Conditions
Keywords
Breast Neoplasms, prevention & control, Epigallocatechin gallate, Dermatitis
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.
Interventions
DRUGEGCG
DRUGplacebo
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer | Each patient will be enrolled for a 5-6 week trial | questionnaire |
Outcome results
None listed