Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine (Sorbolene) Cream

Study Overview
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Brief Summary
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This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.

Detailed Description
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Skin reactions are a common and undesirable result of radiation treatment. Preventative measures are often used although there are few controlled trials. Commonly employed agents for established reactions have included sorbolene (10% Glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. One trial found that Cavilon No-Sting Barrier film reduced Grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents. General Hypothesis: That in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by Cavilon Durable Barrier Cream (CDBC) compared to Sorbolene. Alternative Hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or CDBC respectively. Alternative Hypothesis of secondary outcome: the mean area under the curve (AUC) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or CDBC respectively.

Official Title
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A Paired Double Blind Randomised Comparison of Cavilon(TM) Durable Barrier Cream(TM)[CDBC] to 10% Glycerine (Sorbolene) Cream in the Prophylactic Management of Post-Mastectomy Irradiation Skin Care

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Cavilon (TM) Durable Barrier Cream
* Drug: Sorbolene
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 or more years Post total mastectomy Planned dose at least 45 Gy in 25 fractions ECOG 0-2 Able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy Patients capable of childbearing using adequate contraception Written informed consent Exclusion Criteria: Previous radiotherapy to the chest wall to be treated Macroscopic cutaneous involvement by malignancy at time of radiotherapy Known allergy to product contents Patients who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cavilon (TM) Durable Barrier Cream<br>* Cavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation.<br>Drug: Sorbolene<br>* Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation<br>Radiation: Radiotherapy<br>* Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol<br>* Other names: Radiotherapy, Radiation Therapy;|
| Experimental: 2<br> | Drug: Cavilon (TM) Durable Barrier Cream<br>* Cavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation.<br>Drug: Sorbolene<br>* Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation<br>Radiation: Radiotherapy<br>* Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol<br>* Other names: Radiotherapy, Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin care, Radiotherapy