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Sponsors and Collaborators: |
Trans-Tasman Radiation Oncology Group (TROG) 3M |
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Information provided by: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00193908 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Cavilon (TM) Durable Barrier Cream Drug: Sorbolene |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 330 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | October 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
St George Hospital | |
Kogarah, New South Wales, Australia, 2217 | |
Liverpool Hospital | |
Liverpool, New South Wales, Australia, 1871 | |
Newcastle Mater Misericordiae Hospital | |
Newcastle, New South Wales, Australia, 2298 | |
Wollongong Hospital | |
Wollongong, New South Wales, Australia | |
Westmead Hospital | |
Wentworthville, New South Wales, Australia, 2145 | |
Prince of Wales Hospital | |
Randwick, New South Wales, Australia, 2031 | |
Australia, Queensland | |
Mater QRI | |
South Brisbane, Queensland, Australia, 4101 | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Royal Brisbane Hospital | |
Herston, Queensland, Australia, 4029 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
Andrew Love Cancer Care Centre, Geelong Hospital | |
Geelong, Victoria, Australia, 3220 | |
Australia, Western Australia | |
Royal Perth Hospital | |
Perth, Western Australia, Australia, 6000 |
Study Chair: | Peter Graham | St George Hospital |
Study ID Numbers: | TROG 04.01 |
Study First Received: | September 12, 2005 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00193908 |
Health Authority: | Australia: Human Research Ethics Committee |
Skin care Radiotherapy |
Glycerol Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |