HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer

Study Overview
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Brief Summary
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This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.

Detailed Description
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Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.

Official Title
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Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: HylaCare
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age 18 or older Diagnosis of breast cancer Intact breast (not surgically absent) Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions) Ability to understand and comply with the requirements of this study Ability to give Informed Consent For sexually active females, patient agrees to use acceptable method of birth control Exclusion Criteria: Women who are pregnant or lactating Use of concomitant skin care preparations at any of the treated or control portal areas to be observed Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis Severe renal failure creatinine > 3.0 within 6 months of study registration Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo Planned relocation which would make follow-up visits impossible during the course of the study Collagen vascular disease such as Lupus, or scleroderma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HylaCare<br>HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. | Drug: HylaCare<br>* cream<br>|
| Placebo Comparator: Placebo<br>The patient is her own control. | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Skin Toxicity Per NCI-CTC v4.0 | NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity. | Week 5 during radiation therapy | 
| Acute Skin Toxicity Per NCI-CTC v4.0 | NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity. | Week 2 post-radiation therapy | 
| Acute Skin Toxicity Per Investigator Grading Scale | Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema = erythema with dry desquamation = wet desquamation </= 2 cm = wet desquamation from 2.1 - 5cm = wet desquamation from 5.1 - 9 cm = wet desquamation > 9.1 cm | Week 5 during radiation therapy | 
| Acute Skin Toxicity Per Investigator Grading Scale | Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema = erythema with dry desquamation = wet desquamation </= 2 cm = wet desquamation from 2.1 - 5cm = wet desquamation from 5.1 - 9 cm = wet desquamation > 9.1 cm | Week 2 post-radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Acute skin toxicity, as measured by number of participants with skin reactions via self assessment | Week 5 during radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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external beam radiotherapy, breast cancer