Trial Information

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

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.