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Trial registered on ANZCTR


Registration number
ACTRN12607000100493
Ethics application status
Approved
Date submitted
28/07/2004
Date registered
28/07/2004
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public 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
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 04.01 - 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 to reduce overall skin reactions.
Secondary ID [1] 82 0
National Clinical Trials Registry: NCTR587
Secondary ID [2] 83 0
ClinicalTrials.gov: NCT00193908
Universal Trial Number (UTN)
Trial acronym
TROG 04.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-mastectomy 54 0
Condition category
Condition code
Other 60 60 0 0
Breast
Other 61 61 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test Group 1: Apply Cavilon TM Durable Barrier Cream TM (CDBC - 1.3% dimethicone) to medial of the breast and sorbolene (10% Glycerine) to lateral side. Applied from day 1 post X-Ray Therapy (XRT) until 2 weeks XRT (approximately 7 weeks). All products applied topically.
Test Group 2: Apply Cavilon TM Durable Barrier Cream TM (CDBC- 1.3% dimethicone) to lateral side of the breast and sorbolene (10% Glycerine) to the medial side. Applied from day 1 post X-Ray Therapy (XRT) until 2 weeks XRT (approximately 7 weeks). All products applied topically.
NB. The dose of the creams is daily application of a thin film to the treated area.
Intervention code [1] 1498 0
Treatment: Other
Comparator / control treatment
Cavilon TM Durable Barrier Cream TM (CDBC - 1.3% dimethicone)
Control group
Active

Outcomes
Primary outcome [1] 106 0
Skin Acute Toxicity using NCI Common Terminology Criteria for Adverse Events v3.0 acute skin scoring.
Also measured by:
1. Clinician (radiation oncologist or nurse) score of skin reactions.
2. Digital photo for blinded evaluation.
3. Patient comfort scores.
Timepoint [1] 106 0
Weekly skin scoring during XRT treatment and weekly skin assessments continue until week 12 or until resolution of skin reaction.
Secondary outcome [1] 231 0
None
Timepoint [1] 231 0
Nil

Eligibility
Key inclusion criteria
1. Age 18 or more years. No upper limit.2. Post total mastectomy. Timing is not of relevance to this study therefore no limit.3. Planned dose at least 45 Gy in 25 fractions.4. Eastern Co-operative Oncology Group (ECOG) 0-2.5. Able to attend weekly during treatment for review and photo and up to 6 weeks after radiotherpay if reaction does not resolve prior.6. Patients capable of childbearing using adequate contraception.7. written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:1. previous radiotherapy to the chest wall to be treated, either as definitive treatment or as entry/exit dose from previuos intra-thoracic malignancy radiotherapy.2. Macroscopic cutaneous involvement by malignancy at time of radiotherapy.3. patients who are pregnant or lactating4. known allergy to product contents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation: treatment centre. Simple randomisation by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, treating physicians/nurses, statistician
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 4731 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4732 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [3] 4733 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 4734 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 4735 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 4736 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 4737 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 4738 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 4739 0
St George Hospital - Kogarah
Recruitment hospital [10] 4740 0
Westmead Private Hospital - Westmead
Recruitment hospital [11] 4741 0
Wollongong Hospital - Wollongong
Recruitment hospital [12] 4742 0
Mater Private Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 92 0
Commercial sector/Industry
Name [1] 92 0
3M supply the cavilon and sorbolene creams
Address [1] 92 0
3M Australia
950 Pacific Hwy
Pymble, NSW, 2073
Country [1] 92 0
Australia
Funding source category [2] 93 0
Hospital
Name [2] 93 0
St George Clinical Trials Unit
Address [2] 93 0
Cancer Care Centre St George Hospital Kogarah NSW 2217
Country [2] 93 0
Australia
Primary sponsor type
Individual
Name
Peter Graham
Address
Cancer Care Centre St George Hospital Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 70 0
Other Collaborative groups
Name [1] 70 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 70 0
Edith St Waratah NSW 2298
Country [1] 70 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 800 0
Geelong Hospital
Ethics committee address [1] 800 0
Geelong, VIC
Ethics committee country [1] 800 0
Australia
Date submitted for ethics approval [1] 800 0
Approval date [1] 800 0
10/10/2003
Ethics approval number [1] 800 0
Ethics committee name [2] 801 0
Liverpool Hospital
Ethics committee address [2] 801 0
Liverpool, NSW
Ethics committee country [2] 801 0
Australia
Date submitted for ethics approval [2] 801 0
Approval date [2] 801 0
Ethics approval number [2] 801 0
Ethics committee name [3] 802 0
Mater Centre, QRI
Ethics committee address [3] 802 0
South Brisbane, QLD
Ethics committee country [3] 802 0
Australia
Date submitted for ethics approval [3] 802 0
Approval date [3] 802 0
Ethics approval number [3] 802 0
Ethics committee name [4] 803 0
Calvary Mater Newcastle
Ethics committee address [4] 803 0
Waratah, NSW
Ethics committee country [4] 803 0
Australia
Date submitted for ethics approval [4] 803 0
Approval date [4] 803 0
Ethics approval number [4] 803 0
Ethics committee name [5] 804 0
Prince of Wales Hospital
Ethics committee address [5] 804 0
Randwick, NSW
Ethics committee country [5] 804 0
Australia
Date submitted for ethics approval [5] 804 0
Approval date [5] 804 0
Ethics approval number [5] 804 0
Ethics committee name [6] 805 0
Princess Alexandra Hospital
Ethics committee address [6] 805 0
Brisbane, QLD
Ethics committee country [6] 805 0
Australia
Date submitted for ethics approval [6] 805 0
Approval date [6] 805 0
Ethics approval number [6] 805 0
Ethics committee name [7] 806 0
Royal Adelaide Hospital
Ethics committee address [7] 806 0
Adelaide, SA
Ethics committee country [7] 806 0
Australia
Date submitted for ethics approval [7] 806 0
Approval date [7] 806 0
Ethics approval number [7] 806 0
Ethics committee name [8] 807 0
Royal Brisbane Hospital
Ethics committee address [8] 807 0
Brisbane, QLD
Ethics committee country [8] 807 0
Australia
Date submitted for ethics approval [8] 807 0
Approval date [8] 807 0
Ethics approval number [8] 807 0
Ethics committee name [9] 808 0
Royal Perth Hospital
Ethics committee address [9] 808 0
Perth, WA
Ethics committee country [9] 808 0
Australia
Date submitted for ethics approval [9] 808 0
Approval date [9] 808 0
Ethics approval number [9] 808 0
Ethics committee name [10] 809 0
St George Hospital
Ethics committee address [10] 809 0
Kogarah, NSW
Ethics committee country [10] 809 0
Australia
Date submitted for ethics approval [10] 809 0
Approval date [10] 809 0
Ethics approval number [10] 809 0
Ethics committee name [11] 810 0
Westmead Hospital
Ethics committee address [11] 810 0
Wentworhville, NSW
Ethics committee country [11] 810 0
Australia
Date submitted for ethics approval [11] 810 0
Approval date [11] 810 0
Ethics approval number [11] 810 0
Ethics committee name [12] 811 0
Wollongong Hospital
Ethics committee address [12] 811 0
Wollongong, NSW
Ethics committee country [12] 811 0
Australia
Date submitted for ethics approval [12] 811 0
Approval date [12] 811 0
Ethics approval number [12] 811 0

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.
Trial website
Trial related presentations / publications

Graham P, Plant N, Graham J, Browne L, Martin Borg M, Capp A, Delaney, Harvey J, Kenny L, Francis M, Zissiadis Y. Digital photography as source documentation of skin toxicity: An analysis from the Trans Tasman Radiation Oncology Group (TROG) 04.01 Post-Mastectomy Radiation Skin Care Trial. JMIRO. 2012 Aug; 56 (4): 458-463.

Graham PH, Plant N, Browne L, Borg M, Capp A, Delaney G, Harvey J, Kenny L, Francis M, Zissiadis Y. A paired double blind randomised comparison of a moisturising durable barrier cream (MDBC) to 10% glycerine ("Sorbolene") cream in the prophylactic management of post-mastectomy irradiation skin care. Trans Tasman Radiation Oncology Group (TROG) 04.01. Internat J Radiat Oncol Biol Phys. 2013 May 1; 85(1): 45-50. Doi: 10.1016/j.ijrobp.2012.12.009.
Public notes

Contacts
Principal investigator
Name 27432 0
Miss Natalie Plant
Address 27432 0
Cancer Care Centre St George Hospital Kogarah NSW 2217
Country 27432 0
Australia
Phone 27432 0
+61 2 9350 2844
Fax 27432 0
Email 27432 0
Natalie.Plant@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 10687 0
Miss Natalie Plant
Address 10687 0
Cancer Care Centre
St George Hospital
Kogarah NSW 2217
Country 10687 0
Australia
Phone 10687 0
+61 2 9350 2844
Fax 10687 0
+61 2 9350 2960
Email 10687 0
Natalie.Plant@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1615 0
Prof Peter Graham
Address 1615 0
Cancer Care Centre
St George Hospital
Kogarah NSW 2217
Country 1615 0
Australia
Phone 1615 0
+61 2 9350 3934
Fax 1615 0
+61 2 9350 3958
Email 1615 0
Peter.Graham@SESIAHS.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary