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Spots Global Cancer Trial Database for Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Peter Graham

Affiliation: St George Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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