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

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ClinicalTrials.gov Identifier: NCT02580279
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Dermatitis Prevention & Control Epigallocatechin Gallate Drug: EGCG Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
Study Start Date : December 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: EGCG group
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.
Drug: EGCG
Placebo Comparator: placebo
The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.
Drug: placebo



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
    questionnaire



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580279


Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Study Chair: Ligang Xing, MD,PhD Shandong Cancer Hospital and Institute

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Responsible Party: Han Xi Zhao, Principal Investigator, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02580279     History of Changes
Other Study ID Numbers: GTEBC-2015
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Keywords provided by Han Xi Zhao, Shandong Cancer Hospital and Institute:
Breast Neoplasms
prevention & control
Epigallocatechin gallate
Dermatitis
Additional relevant MeSH terms:
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Breast Neoplasms
Dermatitis
Neoplasms
Skin Diseases
Neoplasms by Site
Breast Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents