Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
NCT ID: NCT00193908
Last Updated: 2009-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2004-03-31
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Cavilon (TM) Durable Barrier Cream
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.
Sorbolene
Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
Radiotherapy
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
2
Cavilon (TM) Durable Barrier Cream
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.
Sorbolene
Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
Radiotherapy
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
Interventions
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Cavilon (TM) Durable Barrier Cream
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.
Sorbolene
Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
Radiotherapy
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Macroscopic cutaneous involvement by malignancy at time of radiotherapy
* Known allergy to product contents
* Patients who are pregnant or lactating.
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Trans Tasman Radiation Oncology Group (TROG)
Principal Investigators
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Peter Graham
Role: STUDY_CHAIR
St George Hospital
Locations
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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
Countries
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References
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Graham PH, Plant N, Graham JL, Browne L, Borg M, Capp A, Delaney GP, Harvey J, Kenny L, Francis M, Zissiadis Y. A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01. Int J Radiat Oncol Biol Phys. 2013 May 1;86(1):45-50. doi: 10.1016/j.ijrobp.2012.12.009. Epub 2013 Feb 12.
Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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TROG 04.01
Identifier Type: -
Identifier Source: org_study_id
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