Clinical trial NCT02580279: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Dermatitis
Prevention & Control
Epigallocatechin Gallate
Keywords: Breast Neoplasms
prevention & control
Epigallocatechin gallate
Dermatitis
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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
timeFrame: 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
timeFrame: Each patient will be enrolled for a 5-6 week trial
measure: Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer
timeFrame: Each patient will be enrolled for a 5-6 week trial
Other outcomes:
Locations:
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Ligang Xing, MD,PhD
role: STUDY_CHAIR
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.