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
1 other identifier
interventional
333
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Mar 2004
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 14, 2009
May 1, 2009
3.5 years
September 12, 2005
May 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
12 weeks
Secondary Outcomes (1)
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
12 weeks
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trans Tasman Radiation Oncology Grouplead
- 3Mcollaborator
Study Sites (12)
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Mater QRI
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Related Publications (1)
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.
PMID: 23414763DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Graham
St George Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
March 1, 2004
Primary Completion
September 1, 2007
Study Completion
October 1, 2008
Last Updated
May 14, 2009
Record last verified: 2009-05