A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy
NCT ID: NCT04190381
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-09-06
2021-12-31
Brief Summary
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Several studies have examined the effects of numerous topical agents to reduce the dryness of skin. However, the reported results have not been clinically significant. Previous studies have shown that deer antler velvet extract possess inflammatory function and repair damaged follicles, sweat glands and sebaceous gland. And biocellulose membrane is a highly efficient media to introduce velvet extract to damaged skin tissue.
In this study, velvet extract combined with biocellolose membrane will be used in breast cancer patients to test the safety and efficacy to alleviate their radiation-irritated skin symptoms.
The investigational medical product of this study is a biomedical repair mask, FR-MASK ;the formula of FR-Mask is deer antler velvet, which is a traditional Chinese tonic medicine combined with high-adhesion biocellulose membrane.
The primary objective of this study is to test the safety and clinical outcomes of FR-Mask application in breast cancer patients who have radiation-irritated skin due to the post-operative radiotherapy.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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FR-Mask application
FR-Mask
The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts.
The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.
Interventions
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FR-Mask
The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts.
The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of, non-inflammatory breast adenocarcinoma or in situ breast cancer and completed post-operative radiotherapy without concurrent chemotherapy.
* Breast adenocarcinoma previously treated by unilateral lumpectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
* Patients were scheduled to receive at least three sessions of radiotherapy per week (1 session per day) for at least five weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy.
* A time period of at least two weeks after radiotherapy before beginning the study.
* Participant must give informed consent.
Exclusion Criteria
* Previous radiotherapy to the chest
* Chemotherapy concurrent with radiation treatment
* Prior breast reconstructions, implants, and/or expanders
* Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
* Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
* Participation in any clinical trial in the prior 30 days from baseline.
* Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
20 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Ying-Chun Lin
Attending Physician, Division of Radiation Oncology, Principal Investigator
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ying-Chun Lin
Role: primary
References
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Chen X, Wang Y, Wu Y, Wang L, Li W. [Protective effects of peptides from velvet antler of Cervus nippon on acute ischemic myocardial injury in rats]. Zhongguo Zhong Yao Za Zhi. 2009 Aug;34(15):1971-4. Chinese.
Suh JS, Eun JS, So JN, Seo JT, Jhon GJ. Phagocytic activity of ethyl alcohol fraction of deer antler in murine peritoneal macrophage. Biol Pharm Bull. 1999 Sep;22(9):932-5. doi: 10.1248/bpb.22.932.
Kim KS, Choi YH, Kim KH, Lee YC, Kim CH, Moon SH, Kang SG, Park YG. Protective and anti-arthritic effects of deer antler aqua-acupuncture (DAA), inhibiting dihydroorotate dehydrogenase, on phosphate ions-mediated chondrocyte apoptosis and rat collagen-induced arthritis. Int Immunopharmacol. 2004 Jul;4(7):963-73. doi: 10.1016/j.intimp.2004.04.010.
Fraser A, Haines SR, Stuart EC, Scandlyn MJ, Alexander A, Somers-Edgar TJ, Rosengren RJ. Deer velvet supplementation decreases the grade and metastasis of azoxymethane-induced colon cancer in the male rat. Food Chem Toxicol. 2010 May;48(5):1288-92. doi: 10.1016/j.fct.2010.02.024. Epub 2010 Feb 20.
Kuo CY, Wang T, Dai TY, Wang CH, Chen KN, Chen YP, Chen MJ. Effect of the Velvet Antler of Formosan Sambar Deer (Cervus unicolor swinhoei) on the Prevention of an Allergic Airway Response in Mice. Evid Based Complement Alternat Med. 2012;2012:481318. doi: 10.1155/2012/481318. Epub 2012 Dec 23.
Other Identifiers
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CMUH108-REC3-090
Identifier Type: -
Identifier Source: org_study_id