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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00193908
Registration number
NCT00193908
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
14/05/2009
Titles & IDs
Public title
Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
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Scientific 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
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Secondary ID [1]
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TROG 04.01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cavilon (TM) Durable Barrier Cream
Treatment: Drugs - Sorbolene
Treatment: Other - Radiotherapy
Experimental: 1 -
Experimental: 2 -
Treatment: Drugs: 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.
Treatment: Drugs: Sorbolene
Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
Treatment: Other: Radiotherapy
Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
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Assessment method [1]
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
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Assessment method [1]
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Timepoint [1]
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12 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
333
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Recruitment hospital [2]
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Calvary Mater Newcastle - Newcastle
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Recruitment hospital [4]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [5]
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Westmead Hospital - Wentworthville
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Recruitment hospital [6]
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Wollongong Hospital - Wollongong
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Recruitment hospital [7]
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Royal Brisbane Hospital - Herston
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Recruitment hospital [8]
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Mater QRI - South Brisbane
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Recruitment hospital [9]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [10]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [11]
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Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
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Recruitment hospital [12]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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1871 - Liverpool
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Recruitment postcode(s) [3]
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2298 - Newcastle
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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2145 - Wentworthville
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Recruitment postcode(s) [6]
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- Wollongong
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Recruitment postcode(s) [7]
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4029 - Herston
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Recruitment postcode(s) [8]
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4101 - South Brisbane
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
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5000 - Adelaide
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Recruitment postcode(s) [11]
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3220 - Geelong
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Recruitment postcode(s) [12]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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3M
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00193908
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter Graham
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Address
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St George Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00193908
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