- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193908
Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New South Wales
-
Kogarah, New South Wales, Australia, 2217
- St George Hospital
-
Liverpool, New South Wales, Australia, 1871
- Liverpool Hospital
-
Newcastle, New South Wales, Australia, 2298
- Calvary Mater Newcastle
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Wentworthville, New South Wales, Australia, 2145
- Westmead Hospital
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Wollongong, New South Wales, Australia
- Wollongong Hospital
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane Hospital
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South Brisbane, Queensland, Australia, 4101
- Mater QRI
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
-
-
Victoria
-
Geelong, Victoria, Australia, 3220
- Andrew Love Cancer Care Centre, Geelong Hospital
-
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 18 or more years
- 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:
- Previous radiotherapy to the chest wall to be treated
- Macroscopic cutaneous involvement by malignancy at time of radiotherapy
- Known allergy to product contents
- Patients who are pregnant or lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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 will be applied to either the medial or the lateral side of the treated breast.
Side will be determined by randomisation
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions.
Planning and Treatment is per the study protocol
Other Names:
|
Experimental: 2
|
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 will be applied to either the medial or the lateral side of the treated breast.
Side will be determined by randomisation
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions.
Planning and Treatment is per the study protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Peter Graham, St George Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TROG 04.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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