The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
Official Title: 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
Study ID: NCT00193908
Brief Summary: 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: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St George Hospital, Kogarah, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Westmead Hospital, Wentworthville, New South Wales, Australia
Wollongong Hospital, Wollongong, New South Wales, Australia
Royal Brisbane Hospital, Herston, Queensland, Australia
Mater QRI, South Brisbane, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Name: Peter Graham
Affiliation: St George Hospital
Role: STUDY_CHAIR