Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Study Overview
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Brief Summary
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Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

Detailed Description
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The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Official Title
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Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

Conditions
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Radiodermatitis

Intervention / Treatment
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* Drug: Difinsa53
* Drug: Aquaphor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years and older Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast Able to apply lotion to treatment area at least twice daily during radiation course All surgical sites healed No evidence of infection No history of sensitivity to any component in Aquaphor or Difensa53 Exclusion Criteria: Prior history of radiation therapy (RT) to that site Known dermatologic conditions affecting skin in radiation port Concurrent chemotherapy Skin infection in radiation port History of sensitivity to Aquaphor or Difensa53 component
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor | Drug: Difinsa53<br>* Difinsa53 cream is applied to one half of radiation field<br>* Other names: Dimethicone;Drug: Aquaphor<br>* Aquaphor is applied to one half of radiation field<br>* Other names: petrolatum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatitis, breast cancer, radiation